~
NEWS AND NEW ITEMS ~
Latest News and Press releases
from the optical industry - Archived
Updated
05/04/2008 |
 Chemical
Nano Technology |
This page has been set up to give you, the visitor a look
of what happens in the optical industry in the way of interesting press
releases. Mergers, takeovers and more. The news will be archived so that a
while down the road we can still look at them.
New
Optical News / Press Releases
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OPTICAL
NEWS / PRESS
RELEASES / ARCHIVES
05/04/2008
Oakley/Luxottica Group: A Merger of Enemies?
Posted on Jul 9th, 2007 with stocks:
LUX,
OO
( OO)
- Luxottica Group S.p.A. ( LUX)
merger is one of the more interesting deals to
surface in quite some time. Not only are the
companies direct competitors in the production
and distribution of eyewear, they have a long
history of legal battles and open animosity
towards each other that has played out like a
soap opera over the years. Thus, it was a
surprise, to say the least, when this deal
was announced two weeks ago.
On the surface, Oakley is primarily a
manufacturing of specialty eyewear (its
sunglasses have obtained iconic status
internationally), with its products being
distributed through third-party retailers or
directly via on-line sales. Internationally,
Oakley owns less than 250 retail outlets,
while its products are sold at more than 11,000
retail outlets in the U.S. alone. Clearly, the
company should not be considered a retailer, as
much as a manufacturer and marketer of its own
products.
Read the whole story:
http://72.14.205.104/search?q=cache:...n&ct=clnk&cd=1
|
She also snagged $2,000
worth of sunglasses from Luxottica
According to People.com she walked away
with:
"...seven bags of swag, including shorts and hoodies from L.A.M.B., a
straw hat from Milk Boutique, a pair of Cosabella pushup bras and, according to
a source, about $8,000 worth of pieces from Lia Sophia's Rue Royal jewelry line.
She also snagged $2,000 worth of sunglasses from
Luxottica, including red and white pairs of Wayfarers not yet available in
stores. Said Lohan of her visit to the gift suite: "I cleaned it out. I got some
really cool Ray-Bans, too."
See the whole story at:
http://no-fing-way.blogspot.com/
AP
Luxottica Buying Oakley
for $2.1 Billion
Wednesday June 20, 11:02 pm ET
Luxottica Buying Fellow Eyewear Maker Oakley for $2.1
Billion
NEW YORK (AP) -- Luxottica Group SpA said late Wednesday it will
acquire fellow eyewear maker Oakley Inc. for $2.1 billion, or $29.30
a share, in cash.
Oakley's board will recommend the offer to shareholders for
approval. The deal is expected to close in the second half of this
year, pending normal closing conditions.
Jim Jannard, chairman and founder of Foothill Ranch,
Calif.-based Oakley, said he is excited that the
companies have found a way to join forces.
"Oakley's technology and performance is one of the
world's best kept secrets and this partnership should
empower our ability to tell our story throughout the
world," Jannard said in a statement. "Oakley will
continue to be Oakley but with much greater resources
and a platform for realizing the true potential of our
brand and company."
Luxottica, based in Milan, Italy, has more than 5,800
optical and sun retail stores worldwide and makes
eyewear under brands such as Ray-Ban and Chanel.
|
|
Department
of Health and Human Services
Public Health Service
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
October 31, 2006
VIA FEDERAL EXPRESS
WARNING LETTER
(07-ATL-01)
Ronald L. Zarrella, Chairman and CEO
Bausch & Lomb
One Bausch & Lomb Place
Rochester, NY 14604
Dear Mr. Zarrella:
During an inspection of your facility located at 8507 Pelham Rd.,
Greenville, SC 29615, on March 22, 2006 through May 15, 2006, investigators
from the United States Food and Drug Administration (FDA) determined that
your firm manufactures contact lens solutions. Under section 201(h) of the
Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these
products are devices because they are intended for use in the diagnosis of
disease or other conditions or in the cure, mitigation, treatment, or
prevention of disease, or are intended to affect the structure or function
of the body.
This inspection revealed that these devices are adulterated within the
meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the
methods used in, or the facilities or controls used for, their manufacture,
packing, storage, or installation are not in conformity with the Current
Good Manufacturing Practice (CGMP) requirements of the Quality System (QS)
regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part
820. We reviewed and considered the responses from Mr. Michael Santalucia,
VP Regulatory Affairs, dated June 30, 2006, concerning our investigators'
observations noted on the FORM FDA 483, Inspectional Observations, that was
issued to Mr. Thomas H. Eggleton, VP of Operations. We also acknowledge the
recent receipt of your quarterly update dated October 12, 2006, which we
will continue to review to help us determine the adequacy of your firm's
corrections.
Based on the information we have reviewed, we acknowledge your efforts to
address the outstanding inspection deficiencies noted during our March 22 -
May 15, 2006 inspection. Also, we acknowledge that Bausch and Lomb has
recalled all MoistureLoc contact lens solution worldwide to eliminate the
serious risk to health associated with an outbreak of Fusarium keratitis.
Although the March - May 2006 inspection focused primarily on the
MoistureLoc contact lens solution, the inspection, nonetheless, identified
and documented significant QS regulation violations that were systemic and
are relevant to all products manufactured at the Greenville, SC facility.
However, during the inspection we did not find problems with the other
products currently manufactured at this facility that would warrant product
recall or field correction.
Violations noted during the inspection include, but are not limited to, the
following:
1. Failure to establish and maintain design plans that describe or reference
the design and development activities, and identify and describe the
interfaces with other groups or activities, as required by 21 CFR 820.30(b).
Specifically, the initial design plan shows Project R0151 began in 2001 and
resulted in product [redacted]. The formulation contains a different
preservative [redacted] and was cleared by the Agency in 2003. The
product was not commercialized by your firm. Project R0324 is an alternate
product project ReNu with MoistureLoc Multi-Purpose Solution containing
Alexidine, which was added to the same original design and development plan
in 2004. Initial feasibility and risk assessment show the two products with
two preservative agents [redacted] Alexidine) under one design
project . The design plan provided to our investigators dated October 25,
2001 - February 4, 2003, does not include any activities relating to the
[redacted] solution, ReNu with MoistureLoc Multi-Purpose Solution.
A discussion of your response to this observation is combined with the
review of item # 3 below.
2. Failure to adequately ensure that when the results of a process cannot be
fully verified by subsequent inspection and test, that the process shall be
validated with a high degree of assurance and approved according to
established procedures, as required by 21 CFR 820.75(a).
Specifically,
(a) Raw material specifications were not determined and firmly established
prior to process validation. For example, [redacted] was used for
pre-clinical and clinical studies however; the product formulation was
changed to [redacted] at initial validation then back to
[redacted]
(b) Your firm does not have complete validation data for ReNu with
MoistureLoc Multi-Purpose Solution [redacted]. Initial scale-up
activities at the Greenville plant were performed in 2003 on an unnamed
similar product [redacted] utilizing [redacted] in the product
formulation. [redacted] replaced [redacted] (which was used in
the original product formulation for pre-clinical and clinical studies)
after white particles were noted on soft contact lens while performing a
lens compatibility study. The [redacted] product was formulated with
and used in the validation study; however, the formulation was not
commercialized In 2004 your firm performed a limited validation study on the
currently marketed ReNu with MoistureLoc Multi-Purpose Solution utilizing
[redacted] in the product formulation. The corrective action to avoid
the appearance of white particles on the lenses was to use the [redacted]
with a European Pharmacopeia clarity test. The validation data available
shows that cleaning of the bulk mix tanks and filling lines, the filling
process, the hold time study, and purging processes were not revalidated.
Chemistry testing was limited to the compounding batches and no USP
sterility testing was performed for the scaled-up batches of ReNu with
MoistureLoc Multi-
purpose Solution. [redacted] validation data was accepted in lieu of
performing a complete re-validation of the manufacturing processes. The
validation of the product did not include an evaluation of cleaning,
purging, or filling. No hold time studies or purge evaluations were done.
Lastly, no tank or filter sterilizations were done for ReNu with MoistureLoc
although its ingredients, Alexidine [redacted] and Poloxamine, are
sterile additions.
Your firm's response to observation 6a is inadequate. Your firm has stated
that it will revise SOP 90-008, Validation Program, to perform complete
validation for any new product or formulation at the site. Your firm has
stated that it will revise SOP 90-044, Preparation of Validation Protocols
and Final Reports, to require R&D Process Development and Global Quality to
approve the protocols and reports for new or transferred products. Your firm
has also begun to perform audits to evaluate the effectiveness of the
system. This is inadequate as your firm has not completed any of these
actions and submitted documentation of them to FDA for review.
(c) The following deviations are noted in the initial validation study
[redacted]
1. The European Pharmacopeia (EP) clarity test was not performed on Lot #
234068 [redacted] that was used in the 2003 validation study. Raw
material specifications included a requirement for the EP clarity test in
2003.
Your firm's response to observation 6b1 is inadequate. Your firm has
proposed to revise SOP 60-052, In-process, Final Product, and Raw Material
Chemical Testing, to include an independent QA review and approval of the
requirement before it is released for use. You proposed to revise SOP
90-074, New Product Assessment Planning, to include the requirement for
effective raw material specifications prior to the start of the validation.
This response is inadequate as your firm has not completed these revisions
and submitted them to FDA for review.
2. Bacteriostasis/Fungistasis (B/F) testing was not performed for all
validation runs as specified in the established protocol (0308-ME-0154).
[redacted] runs were performed; however B/F testing was performed on
only one run.
Your firm's June 30, 2006, response to observation 6b2 is inadequate.
Your company has committed to write an addendum to the validation report for
the bacteriostasis/fungistasis testing explaining the deviation. In addition
to writing an addendum to the validation report for the B/F testing
explaining the deviation, the "erroneous protocol" should be revised and
updated to remove the requirement in 0308-ME-0154 for the B/F test to be
repeated for each validation lot to ensure that protocols and company policy
is consistent.
3. The first bottle out of filling on the third batch (PJ3004) was out of
specification on the lower end for Osmolality ([redacted]mOsm/Kg). At
the time of fill, the release specification was [redacted] mOsm/Kg.
The release specification was subsequently lowered to [redacted]t
mOsm/Kg. and this run was accepted.
Your firm's response to observation 6b3 is inadequate . Your firm states
that they will develop a procedure to control specifications prior to scale
up of product or manufacturing and revise SOP 90-008, Validation Program, to
state that when specification changes are identified during a validation,
the validation must be started from the beginning. However, this procedure
has not been developed and submitted to FDA for review.
3. Failure to establish and maintain procedures for verifying the device
design which confirm that the design output meets the design input
requirements, as required by 21 CFR 820.30(f). Specifically,
(a) Tasks for determining analytical in-process and finished product
specifications were not assigned in the design plan and they were not firmly
established prior to the product launch of Renu with MoistureLoc
Multi-Purpose solution. for example, the Osmolality release specifications
was lowered after beginning process validation. Your firm did not establish
specifications prior to beginning process validation. A specification change
was made after validation.
(b) Your firm does not have a test method to evaluate the degradation of
Alexidine in the ReNu with MoistureLoc Multi-Purpose Solution.
Your firm's response is partially adequate. The portion of the response that
addresses observation 1a-c of the FDA 483 is inadequate. Your firm states
that they will develop a separate Design and Development Plan procedure that
will expand and clarify Project Plan Requirements and address management and
documentation when multiple designs or formulations are moved into
development. The new procedures will require the appropriate tracking of
multiple formulations and assess them against the new procedure. This
response is inadequate as your firm has not made these changes yet and
submitted these revised procedures for review.
The portion of your firm's response that addresses observation Id, appears
adequate. Your finn states that you have a method for evaluating Alexidine.
Your company provided TP-8230, HPLC Quantitative Determination of Alexidine
[redacted] which is an assay method that quantifies the level of
Alexidine in the presence of interfering degradant peaks for Alexidine and
other formulation excipients. Your firm also provided the validation report
for this evaluation.
4. Failure to establish and maintain procedures to ensure that the device
design is correctly translated into production specifications, as required
by 21 CFR 820.30(h). Specifically, the design history file does not contain
a statement of readiness from R&D as required in established procedure
BL-POL-401, Product Development Management Process.
Your firm's response to observation le is inadequate. Your firm has stated
that it will revise BLPOL-401, Product Development Management Process for
Medical Devices, to remove the duplicative "Statement of Readiness"
requirement since your firm has a signature mechanism in place that confirms
that each team member is ready to move to the next phase of the process.
This response is inadequate as your firm has not completed the revision of
the procedure and submitted it to FDA for review.
5. Failure to establish and maintain procedures to ensure that the
design requirements relating to a device include a mechanism for
addressing incomplete, ambiguous, or conflicting requirements, as
required by 21 CFR 820.30(c). Specifically, several design inputs for
ReNu with MoistureLoc Multi-Purpose Solution [redacted] are
outstanding and were not addressed by the project team before bringing
the product to the market. For example, the following value added design
inputs remain open: qualification of a [redacted] regimen for the
[redacted]; [redacted] of cycled lenses [redacted]
with [redacted] lenses [redacted] ISO/FDA 11, Regimen Test
using [redacted] and [redacted] after [redacted]
day soak in glass vials; laboratory cleaning study to demonstrate lipid
removal with [redacted] lenses; and, a biocidal efficacy study
that demonstrates efficacy against "clinically significant
microorganisms" (non-ISO organisms). The value added design goals and
design outputs were not completed prior to finalizing the project.
Your firm's response to observation 2 is inadequate. Your firm states
that it will revise documentation and associated design control
procedures to allow for only required design inputs on the Design
Control matrix and provide training to all Project Managers and team
members, however, these revisions have not been completed and submitted
to FDA for review.
6. Failure to ensure that formal documented reviews of the design
results are planned and conducted at appropriate stages of the device's
design development, as required by 21 CFR 820.30(e). Specifically, the
post-launch product review for the ReNu with MoistureLoc Multi- Purpose
Solution has not been performed as required in the formally established
procedures, BLPRO-408, Project Post Launch Review. The review should
occur during the first year after the product is launched. ReNu with
MoistureLoc Multi-Purpose Solution was initially distributed from the
Greenville site in August 2004. No post-launch has been currently done.
Your firm's response to observation 3 is partially adequate . Your firm
has conducted and submitted a copy of the Post Launch Review for ReNu
with MoistureLoc on June 23, 2006. Your firm has also stated that it
will revise procedures to require that quality related reviews be
conducted at specific post-launch time periods after product launch and
train all personnel on the new procedures. Your firm also states that
they will conduct reviews of quality-related information for all
products that have launched within the last 24 months. This portion of
your firm's response to observation 3 is inadequate as your firm has not
completed these revisions and submitted them to the Agency for review .
Additionally, your firm should be conducting reviews for all products
lines, not only those launched in the last 24 months.
7. Failure to establish procedures for quality audits and conduct such
audits to assure that the quality system is in compliance with the
established quality system requirements of the quality system, as
required by 21 CFR 820.22. Specifically,
a) Review of the Internal Audit schedule indicated that your firm has
not conducted or established a routine auditing of your complaint
handling system.
b) Your firm does not have procedures defining the frequency by which
supplier audits will be conducted.
c) Your firm has never audited the supplier of Polyquatemium-10
[redacted] a component used to manufacture ReNu with MoistureLoc
Multi-Purpose Solution.
d) Contract laboratories/suppliers used in raw material and finished
product testing have not been audited at a defined frequency. For
example:
-Lab A was last audited on December 11, 1998.
-Supplier A was last audited on September 11, 2001.
-The last biennial audit of Lab B was conducted on December 3, 2003.
Your firm's response to observation 11 is inadequate. Your firm has
stated that it has completed audits for the supplier of
polyquaternium-10 on June 2, 2006, Lab A on May 31, 2006, Lab B on May
24-25, 2006, and Supplier A on June 8, 2006, however, you did not
provide documentation of these audits. Your firm has also stated that it
will revise BL-PRO-1701, Global Quality System Audits, assess and modify
its supplier management program, and revise metrics for the supplier
management program. Your firm has not completed these revisions and
submitted them to FDA for review.
8. Failure to establish and maintain procedures to prevent contamination
of equipment or product by substances that could reasonably be expected
to have an adverse effect on product quality, as required as 21 CFR
820.70(e). Specifically,
a) On April 19, 2006, in the upper mix room, peeling paint and paint
chips were observed on agitators located on the tops of tank
[redacted], and the solenoid above tank #[redacted]. These
tanks are currently used for the production of contact lens solutions.
Your firm's response to observation 7a is inadequate. Your firm has
installed stainless shields in between motor housings that contain
peeling paint on June 9, 2006. You have replaced painted solenoid valve
housings with plastic housings on June 10, 2006, and will make other
replacements by the end of 2006. Your firm will revise cleaning
procedures to require periodic cleaning of stainless steel shields and
revise preventative maintenance procedures to require periodic
examination of agitator motor housings for condition and repair. The
response is inadequate until the changes have been completed and
verified by FDA.
b) The cleaning, inspection, and sanitization of fill lines #[redacted]
used in the production of Opcon A, Sensitive Eyes, Boston Cleaner, and
ReNu with Moisture Loc Multi-Purpose Solution were not documented as per
SOP #40-102-19, "Weekly and Monthly Cleaning and Inspection of
[redacted] for the monthly cleaning conducted for the month of
February 2006.
Your firm's response to observation 7b is inadequate. Your firm has
stated that it will retrain all site supervisors in proper change
control and procedure management, however, this training has not been
completed with documentation submitted to FDA for verification.
9. Failure to establish and maintain procedures to adequately control
environmental conditions, as required by 21 CFR 820.70(c). Specifically,
temperature conditions within the aseptic processing area are not being
documented to ensure such conditions are consistently within established
specifications of [redacted] degrees Celsius.
Your finn's response to observation 8 is inadequate. Your firm has
stated that it has updated the Preventative Maintenance Task List to
include space to record specific temperature readings on April 27, 2006.
Your company has stated that it will conduct an audit to identify and
enhance other temperature documentation practices and will install a
continuous temperature and humidity recording system. Your firm has not
provided the updated task list to FDA and the temperature audit has not
been completed.
10. Failure to ensure that all equipment used in the manufacturing
process meets specifications and is appropriately designed, constructed,
placed, and installed to facilitate maintenance, adjustment, cleaning,
and use, as required by 21 CFR 820.70(g) . Specifically, on March 27,
2006, clean, uncapped product transfer hoses that are used in production
were observed in direct contact with a shelving unit upon which a
visible layer of a white powdery residue was observed. The shelving unit
was installed to prevent hoses from coming in contact with the
manufacturing room floor.
Your firm's response to observation 13 is inadequate. Your firm states
that it revised SOP 40-072, Routine Cleaning of the Pharmacy, Upper Mix
and Lower Mix, on May 20, 2006, to require weekly cleaning of the
shelving unit in the Upper Mix Area and trained personnel on the new
procedures on May 23, 2006. Your firm has not submitted the revised
procedures for review.
11. Failure to document maintenance activities, including the date and
individuals performing the maintenance activities, as required by 21 CFR
820.70(g)(1). Specifically, integrity testing of the vent filters on the
[redacted] Hot Purified Water (HPW) tanks was not conducted
during the six month interval between June 2005 and March 2006 per SOP #
50-095-08.
Your firm's response to observation 14 is inadequate as your firm states
that it has corrected the preventative maintenance task form to require
filter testing every4Mmonths. Your firm has stated that it will revise
SOP 50-001, Preventative Maintenance Program, to require that any
changes to the Preventative Maintenance System go through the formal
change control process as well as review changes that have been made to
the Preventative Maintenance Program to ensure they are not in conflict
with existing procedures . Your firm has not provided the task form and
has not completed the revisions to these procedures and submitted them
for review by FDA.
12. Failure to review, evaluate, and investigate any complaint involving
the possible failure of a device labeling, or packaging to meet any of
its specifications, as required by 21 CFR 820.198(c). Specifically,
a) The Fusarium Keratitis investigation did not include sterility or
biocidal testing for ReNu with MoistureLoc Multi-Purpose Solution
product lots implicated in complaints received from Hong Kong.
b) Your firm had not performed sterility testing on the returned/retain
samples in conjunction with the Fusarium investigation for complaints
received from Malaysia and Singapore.
Your firm's response to observation 9 is inadequate. Your firm states
that it has updated the complaint investigation for reports of
infectious keratitis to include modified bioburden and biocidal testing
for ReNu with MoistureLoc and ReNu MultiPlus on May 8, 2006. Your firm
states that it will also evaluate and modify complaint investigation
procedures to include modified bioburden and biocidal testing for
complaint categories. Your firm has not submitted these documents for
review.
13. Failure to establish and maintain procedures to ensure that mix-ups,
damage, deterioration, contamination, or other adverse effects to
product do not occur during handling, as required by 21 CFR 820.140.
Specifically,
a) No documentation, inspection, audit, or checklist were established or
conducted to guarantee that the trucking company transporting finished
product from the manufacturing plant to the distribution center is
protecting materials and finished product from damage and contamination
as specified in SOP #15-006-09. Additionally, the trucking company does
not have a climate control system in the trailer to monitor temperature
conditions.
b) There are no procedures indicating the amount of time finished
products are allowed to remain stored in trailers before finding a
location in the warehouse for storage. Your firm's response to
observation 12 is inadequate. Your firm has stated that it will revise
procedures to require transportation vehicles to be inspected before
loading, after reaching the distribution center and will require them to
be unloaded within [redacted] hours. However, these revisions
have not been completed and submitted for review.
14. Failure to establish and maintain procedures for the control of
storage areas and stock rooms for product to prevent mix-ups, damage,
deterioration, contamination, or other adverse effects, as required by
21 CFR 820.150(a). Specifically,
a) On April 4, 2006, your firm was unable to locate a product lot
implicated in a customer complaint, ReNu with MoistureLoc Multi-Purpose
Solution, Lot# GG5055, which was identified as being part of the current
inventory in your firm's validated inventory control systems
[redacted] and [redacted].
b) On April 24, 2006, your firm was unable to locate sixteen (16) cases
of ReNu with MoistureLoc Multi-Purpose Solution, Lot #AJ5065.
c) On May 9, 2006, your firm was unable to locate [redacted]
units of ReNu MultiPlus Multi-Purpose Solution, Lot #GC6061.
Your firm's response to observation 10 is inadequate. Your firm has
stated that it will revise SOP 70-126, Finished Goods Destruction
Notification and Obsolete Inventory/Component Disposition, to require
the tracking of lot numbers; SOP 15-057, Customer Returns Processing to
clarify the documentation review process and expand the license plate
numbering for customer return pallets ; SOP 15-117, Cancellation and/or
Deallocation of Orders/Order Lines to include steps that will be
performed by IT to modify the in-process order line status to indicate
that the line item has been cancelled.
Your firm states that it will also conduct a statistical sampling of
order accuracy before shipping, and modify the inventory system picking
and replenishment processes to provide additional checks to ensure that
only released materials are shipped, and will develop an SOP on the use
and resulting actions of the Open Order Status Report in Customer
Service. These tasks have not been completed and no documentation has
been provided to FDA for verification.
Our inspection also revealed that your contact lens solutions are
misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in
that your firm failed or refused to furnish material or information
respecting the device that is required by or under section 519 of the
Act, 21 U.S.C. 360i and 21 C.F.R. Part 803 - Medical Device Reporting (MDR)
regulation. Significant deviations include, but are not limited to, the
following:
Failure to submit an MDR report within 30 calendar days after receiving
or otherwise becoming aware of information that reasonably suggests that
a marketed device may have caused or contributed to a death or serious
injury, as required by 21 CFR 803.50(a)(1). Specifically, a) Your firm
failed to notify the Agency of 35 serious injury reports of Fusarium
keratitis from Singapore's Minister of Health in February 2006 relating
to ReNu with MoistureLoc Multi-Purpose Solution. None of the complaints
were reported to the Agency as of April 7, 2006.
We have reviewed your response and have concluded that it is inadequate.
A review of your complaint #S106000046, which concerns 26 of the cases
of Fusarium keratitis reported by the Singapore MoH was conducted. The
Office of Surveillance and Biometrics (OSB), CDRH, has determined that
these are MDR reportable serious injuries. On April 6, 2006, your firm
contacted CDRH/OSBIRSMB about the 35 cases from Singapore. Your firm was
told to treat the cases as a literature report and submit a single 3500A
that contained all of the information your firm had from the Singapore
MoH. Your firm was also told that if it received information on new
cases from Singapore MoH this information would need to be submitted as
a new literature report.
The rationale provided in the file for not reporting these events at
both the regulatory affairs and the corporate level is not supported by
the information available to your firm.Your response states that this
information did not reasonably suggest that the ReNu with MoistureLoc
Multi- Purpose Solution device caused or contributed to the Fusarium
infections. FDA disagrees. This information suggested that your ReNu
product may have caused or contributed to the event.
Your response also states that there was insufficient information to
submit MDRs. FDA disagrees. Bausch & Lomb was required to submit the 26
MDRs within 30 days of becoming aware or the events, regardless of how
little information you had. Bausch and Lomb states that it did not
receive adequate input from FDA as to how to submit the MDRs. However,
FDA's guidance document "Medical Device Reporting for Manufacturers" has
been available since March 1997 and can be accessed easily via FDA's
Internet site by choosing Medical Devices, MDR reporting, and then
manufacturers. This document explains that each patient event requires
submission of a separate 3500A. In addition to the guidance document
this site also provides contact information for OSB/RSMB.
b) Complaints #S105000240 - #S105000245 were initially reported to your
firm as keratitis complaints in July 2005. These complaints have not
been reported to the Agency as of May 9, 2006.
FDA agrees with Bausch & Lomb that the 6 cases of Infiltrative Keratitis
included in Complaints #S105000240 - S105000245 are not reportable. It
appears that your firm appropriately investigated these events and
attempted to obtain additional information.
You should take prompt action to correct the violations addressed in
this letter. Failure to promptly correct these violations may result in
regulatory action being initiated by the Food and Drug Administration
without further notice. These actions include, but are not limited to,
seizure, injunction, and/or civil money penalties . Also, federal
agencies are advised of the issuance of all Warning Letters about
devices so that they may take this information into account when
considering the award of contracts. Additionally, premarket approval
applications for Class III devices to which the Quality System
regulation deviations are reasonably related will not be approved until
the violations have been corrected. Requests for Certificates to Foreign
Governments will not be granted until the violations related to the
subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days
from the date you receive this letter of the specific steps you have
taken to correct the noted violations, including an explanation of how
you plan to prevent these violations, or similar violations, from
occurring again. Include documentation of the corrective action you have
taken. If your planned corrections will occur over time, please include
a timetable for implementation of those corrections. If corrective
action cannot be completed within 15 working days, state the reason for
the delay and the time within which the corrections will be completed.
Your response should be sent to the attention of Serene N. Ackall,
Compliance Officer, at the address noted in the letterhead. If you have
any questions about this letter, you can contact Ms. Ackall at
404-253-1296.
Finally, you should know that this letter is not intended to be an
all-inclusive list of the violations at your facility. It is your
responsibility to ensure compliance with applicable laws and regulations
administered by FDA. As noted above, the specific violations noted in
this letter and in the Inspectional Observations, FORM FDA 483 (FDA
483), issued at the closeout of the inspection may be symptomatic of
serious problems in your firm's manufacturing and quality assurance
systems. You should investigate and determine the causes of the
violations, and take prompt actions to correct the violations and to
bring your products into compliance.
Sincerely,
/s/
Mary H. Woleske
Director
Atlanta District Office
UPDATE: Bausch &
Lomb To Cut 400 Contact Lens Jobs
Wednesday September 20th, 2006 / 20h31 |
 |
|
|
(Adds details beginning with the third paragraph.)
By Jon Kamp Of DOW JONES NEWSWIRES Eye-care company Bausch & Lomb Inc. (BOL)
said Wednesday it will cut about 400 jobs at contact lens manufacturing
plants in the U.S. and Europe.
The cuts will mostly affect temporary jobs, and the Rochester, N.Y.,
company said it expects to rehire some of these workers in the new year.
The cuts will affect plants in Rochester; Waterford, Ireland; and
Livingston, Scotland.
Bausch & Lomb noted that it will "continue to adjust its temporary
workforce to meet changing business conditions," as it has done before.
The company said that it had beefed up the temporary workforce to
support a production increase for its "PureVision" silicone hydrogel
contact lens. It also said that it's "transitioning its contact lens
lines, including its one-day products, to newer designs made using more
automated, advanced manufacturing technology."
Bausch & Lomb had to pull its MoistureLoc contact lens solution from the
U.S. market in April, and pull it from shelves around the world in May,
after the solution was associated with a fungal infection of the eye
that can cause blindness.
A Bausch & Lomb filing made with the U.S. Securities and Exchange
Commission last month showed that the MoistureLoc recall has contributed
to a rough year for the company. The company said in the filing that it
expects to post $70 million to $80 million in pretax earnings this year,
down from a previous forecast of $325 million to $335 million that was
made in October 2005, before the major infection concerns surfaced.
The company has said the MoistureLoc solution itself is safe, but that
improper usage could compromise its fungus-fighting ability.
For 2007, Bausch & Lomb said it sees pretax earnings rebounding to $220
million to $270 million on sales of $2.5 billion to $2.625 billion.
The company hasn't officially reported any financial results this year
and has yet to report results for the second half of 2005 due to ongoing
internal investigations of company accounting issues. The company hasn't
specifically estimated when it will file delayed financial reports with
the SEC, but said last month that it would do so "as soon as
practicable."
New York Stock Exchange rules require the company to file its annual
report by Sept. 30 or face delisting. Bausch & Lomb said it would
request an extension from the NYSE if necessary.
Bausch & Lomb shares recently traded down 3 cents at $51.25.
-By Jon Kamp, Dow Jones Newswires; 312-750-4129; jon.kamp@dowjones.com
|
|
|
| Wednesday September
20th, 2006 / 20h31 |
|
|
|
|
Carl Zeiss Vision Acquires
Optoteam
Position in Scandinavia expanded
Purchase of Optoteam effective July 1, 2006.
Aalen, Germany, 14.07.2006.
Effective July 1, 2006, Carl Zeiss Vision, one of the world’s leading
suppliers of spectacle lenses, purchased the Swedish ophthalmic business,
Optoteam.
Based in Trellebrog, Optoteam has been a distributor of Carl Zeiss Vision’s
SOLA and American Optical lenses for several years. In addition to the
distribution of spectacle lenses, Optoteam has made a name for itself as the
North European market leader in the field of safety eyewear. Optoteam has an
organisation consisting of 33 employees. Its customer portfolio includes eye
care professionals in Sweden, Norway, Finland and Denmark.
Bo Lindgren, founder of Optoteam, welcomes the acquisition as an important
step for the future:
“I am pleased to hand over Optoteam to a company with whom we have worked very
closely for many years. The resources of Carl Zeiss Vision lay the optimum
foundations for the future growth of Optoteam.”
“With the acquisition of Optoteam, we are strengthening our organisation in
the Swedish market and in other Northern European countries. The level of
expertise at Optoteam and the close relationships with customers and market
partners fits well with the strategy of Carl Zeiss Vision. We expect that
Optoteam will enhance their market position and benefit from improved growth
opportunities,” adds Flemming Andersen, Nordic Regional Manager at Carl Zeiss
Vision.
Previously Marketing Manager at Optoteam,
Patrik Gustafsson has now been appointed as Managing Director and will head
the company, supported by Market Manager Jakob Ingvaldsen. Jakob Ingvaldsen
worked on the Danish and Norwegian markets for SOLA Nordic, now Carl Zeiss
Vision, for several years.
Bo Lindgren
MD
Optoteam
Phone: +46 410 482 81
Fax: +46 33 06 20
E-Mail:
Flemming Andersen
Nordic Regional Manager
Carl Zeiss Vision
Phone: +45 473 35888
Gsm.: + 45 209 85888
Number: V19/06 EL
__________________
ESSILOR
First-Half 2006 Revenue
| |
Charenton-le-Pont, France (July 20, 2006)
-
Essilor, the world leader in ophthalmic optics, today announced its
consolidated revenue for the six months ended June 30, 2006:
|
€ millions |
1st half 2006 |
1st
half 2005 |
%
change as reported |
Like-for-like change* |
|
Consolidated revenue |
1,361.8 |
1,182.8 |
+15.1% |
+8.7% |
* Based on a comparable scope of consolidation and at constant exchange
rates.
In a generally buoyant environment for the ophthalmic lens
industry, Essilor enjoyed sustained demand for its high value-added lenses
and its new products, led by Varilux Physio®, the new progressive lens which
was introduced worldwide during the first six months of the year.
Organic growth
was strong throughout the period, with revenue up by 11.5% like-for-like in
the first quarter and by a very respectable 6.1% in the second quarter,
despite the high basis of comparison created by the 8.1% increase in the
year-earlier period.
Changes in the scope
of consolidation boosted reported revenue by
3.7%,
reflecting the contributions of the businesses acquired in 2005 as well as
of the first acquisitions made in 2006, which included several prescription
lens laboratories in the United States and stakes in India’s GKB Group and
in the Taiwan-based Polylite Group.
The currency effect
remained positive, at 2.7%; however, the impact was significantly lower
than in first-half 2005 due to the strengthening of the euro against the US
dollar and the Company’s other main currencies.
Revenue
by geographical segment:
|
€ millions |
1st half 2006 |
1st
half 2005 |
%
change as reported |
Like-for-like change* |
|
Europe |
606.3 |
563.2 |
+7.6% |
+6.2% |
|
North
America |
595.4 |
490.4 |
+21.4% |
+10.8% |
|
Asia-Pacific |
116.9 |
95.0 |
+23.0% |
+13.3% |
|
Latin
America |
43.2 |
34.2 |
+26.4% |
+5.8% |
* Based on a comparable scope of consolidation and at constant exchange
rates.
• After a very good first quarter, growth in
Europe slowed to 2.9% like-for-like in the second quarter compared with 7.5%
in the same period of 2005.
• In North America, growth remained strong across all networks, with revenue
up 9.3% like-for-like in the second quarter.
• Asia-Pacific turned in another good performance, with second quarter
revenue up 12.4% like-for-like.
• In Latin America, after a very good start to the year revenue for the
second quarter contracted 3.4% like-for-like, partly reflecting a very high
basis of comparison in Brazil. Revenue in Argentina remained high.
Five US-based prescription lens
laboratories have joined Essilor
As part of its external growth strategy, Essilor acquired
several prescription lens laboratories during the period:
• Future Optics, Inc. based in Largo, Florida.
• Ozarks Optical Laboratories, Inc. based in Springfield, Missouri.
• Precision Optical Laboratory, Inc. based in Gallaway, Tennessee.
• Precision Optical Laboratory, Inc. based in Hartford, Connecticut.
• Homer Optical Company, Inc., the twelfth largest independent laboratory
(1) in the United States, and owner of four prescription lens laboratories
in Maryland, Pennsylvania, Virginia and New York State.
Together, these five companies represent total revenue of
some $30 million.
In all, Essilor has acquired 15 companies since January 1, representing
full-year revenue of €51 million.
(1) According to Vision Monday November 21, 2005 edition.
A
conference call will be held today at 10:00 a.m. Paris time.
The number to dial is: +44 (0)161 601 89 20.
A telephone replay will be available from 1:00 p.m. Paris time and until
July 24, 2006.
Phone number: +44 (0)207 075 32 14.
Pin code : 183580#.
The conference will be available on the Internet for later listening from
2:00 p.m. Paris time, at:
http://hosting.3sens.com/Essilor/20060720-5F96AB45/en.
Next
financial announcement:
First-half earnings will be released on September 7, 2006.
Investor Relations and
Financial Communication
Véronique Gillet
Phone: +33 (0)1 49 77 42 16
www.essilor.com |
| |
|
Press Release
Pearle Vision to become
leading Canadian national optical chain
MILAN, Italy, May 18 /PRNewswire-FirstCall/ -- Luxottica Group S.p.A. (NYSE:
LUX; MTA: LUX) today announced the acquisition of Shoppers Optical, a 74-store
Canadian-based optical chain owned by King Optical Group Inc. After the
closing of the transaction, Luxottica Group will manage a total of 268 optical
stores in Canada.
Valerio Giacobbi, executive vice president of Luxottica Group for North
American retail, commented: "This acquisition, when completed, will allow us
to accelerate our plans to improve coverage of the high potential US$1.4
billion Canadian optical retail sector. It will make our Group the leading
operator of optical stores in the country and the only one with full national
coverage."
Shoppers Optical operates across eight of Canada's provinces. 26 of Shoppers
Optical's stores are based in the province of Ontario, where nearly 40% of the
Canadian population lives.
"One of the key benefits of this acquisition," added Mr. Giacobbi, "is that
the profile of Shoppers Optical's customers is already extremely similar to
that of our Pearle Vision retail brand. Subject to and following closing, we
plan to convert all stores to the Pearle Vision brand, thus allowing us to
more rapidly grow its coverage of the Canadian market while providing Canadian
consumers with improved services and increased product selection."
"Pearle Vision," concluded Mr. Giacobbi, "will become the leading national
optical retail chain in Canada, with a total of 114 stores, and the vehicle
for further growth for our Group in this market.
In fact, its business model offers tremendous potential for profitable growth
thanks to the strength of the Pearle Vision brand -- historically the most
recognized optical retail brand in the U.S., now to be extended into the
Canadian market."
Shoppers Optical's business model is highly synergetic with Luxottica Group's
existing retail operations in Canada. Historically a strong business, it
already enjoys full integration of systems supporting the sales, service and
manufacturing processes. In addition, this acquisition will bring into the
organization the first full-service Canada-based central lens finishing lab
with anti-reflective coating capability, further strengthening the Group's
ability to deliver the highest level of service to the Canadian market.
The closing of the transaction, which is subject to customary closing
conditions, is expected to take place in June 2006.
About Luxottica Group S.p.A. Luxottica Group is a global leader in eyewear,
with nearly 5,500 optical and sun retail stores in North America,
Asia-Pacific, China and Europe and a strong brand portfolio that includes
Ray-Ban, the best selling sun and prescription eyewear brand in the world, as
well as, among others, license brands Bvlgari, Burberry, Chanel, Dolce &
Gabbana, Donna Karan, Prada, Versace and Polo Ralph Lauren, from January 2007,
and key house brands Vogue, Persol, Arnette and REVO. In addition to a global
wholesale network that touches 130 countries, the Group manages leading retail
brands such as LensCrafters and Pearle Vision in North America, OPSM and
Laubman & Pank in Asia-Pacific, and Sunglass Hut globally. The Group's
products are designed and manufactured in six Italy-based high-quality
manufacturing plants and in the only two China- based plants wholly-owned by a
premium eyewear manufacturer. For fiscal year 2005, Luxottica Group (NYSE: LUX;
MTA: LUX) posted consolidated net sales of euro 4.4 billion. Additional
information on the Group is available at
http://www.luxottica.com.
May 18,2006
BAUSCH & LOMB DID NOT REPORT ADVERSE EVENTS FOR
MOISTURE LOC, FDA SAYS
Bausch & Lomb failed to submit a medical device report (MDR) detailing 35
serious injury reports of Fusarium keratitis — the most common form of fungal
keratitis, an infection of the cornea — in contact lens wearers using the firm's
ReNu with MoistureLoc product in Singapore, the FDA said in a Form 483 issued to
the company May 15.
Singapore's Minister of Health reported the incidents to the company in
February, but none of the complaints had been reported to the FDA as of April 7,
the agency said. Five other complaints of Fusarium infection were reported to
the firm in July 2005 but had not been reported to the agency as of May 9. The
firm also did not report its removal of ReNu with MoistureLoc or its
Multi-Purpose solution from the market in Singapore and Hong Kong in February.
The company has been subject to a number of lawsuits from people claiming
injury from the product. A New York man filed a lawsuit against Bausch & Lomb in
federal court April 20, accusing the company of engaging in deceptive marketing
practices and failing to publicly disclose an inherent defect in its ReNu with
MoistureLoc solution that makes the product susceptible to Fusarium keratitis.
Nelson Huie has alleged the company knew of the link between the product and
increased incidences of Fusarium in Asia as early as February, but did not
suspend sales of the product in the U.S. until cases of the infection became
public
ESSILOR
| |
A Good Start To The Year
First-Quarter Revenue Up 11.5% Like-for-Like |
Charenton-le-Pont, France (April 20, 2006)
-- Essilor, the world leader in ophthalmic optics, today announced its
consolidated revenue for the three months ended March 31, 2006:
|
In euros millions |
March
31, 2006 |
March 31,
2005 |
% Change |
Like-for-like growth |
|
Revenue |
692.8 |
570.0 |
21.5% |
11.5% |
|
Europe |
300.0 |
269.1 |
11.5% |
9.8% |
|
North
America |
309.1 |
238.7 |
29.5% |
12.4% |
|
Asia
Pacific |
60.3 |
47.0 |
28.4% |
14.3% |
|
Latine
America |
23.4 |
15.2 |
54.1% |
17.3% |
Revenue for the first three months of 2006 was up 11.5% like-for-like and 21.5%
as reported, in comparison with a relatively weak prior-year period.
Acquisitions made in 2005 and early 2006 added 4% to reported growth, while the
currency effect was a positive 6%, primarily reflecting the increase in the US
dollar, Canadian dollar and Brazilian real against the euro compared with
first-quarter 2005.
In a generally expanding market, the Group reported significant
growth in unit sales and a favorable shift in the product mix. In particular,
the new Varilux Physio® progressive lens, which was launched in high-index
materials during the first quarter, has proven highly popular with consumers and
eyecare professionals alike.
As a result, business improved in Europe, while continuing to
enjoy robust growth in North America, Asia and Latin America.
Recent Acquisitions
Essilor continued to acquire new companies in the first quarter
:
• In New Zealand, Wellington-based
Prolab was acquired and the
stake in Christchurch-based
Olab was raised to 50%. These
two prescription laboratories have combined revenue of US$4 million.
• In India, the Group acquired the assets of
Delta CNC, a laboratory based
in Ahmedabad.
• In the United States,
Uniscoat Inc., a coating facility in California, and
PerfeRx Optical Co., Inc.,
a Varilux® distributor in Massachusetts, were both acquired. The two companies
reported total revenue of US$7 million.
In all, Essilor has acquired ten companies since January 1,
representing full-year revenue of €26 million.
Source: Cooper Companies
LAKE FOREST, Calif., April 11, 2006 (PRIMEZONE) -- CooperVision,
Inc., the contact lens unit of The Cooper Companies, Inc. (NYSE:COO)
announced today that on April 10, 2006 it filed suit in federal
district court in Marshall, Texas, alleging that CIBA Vision's
O2Optix(tm) contact lenses infringe United States Patent Nos.
6,431,706, 6,923,538, 6,467,903, 6,857,740 and 6,971,746, all of which
are assigned to CooperVision. CooperVision is asserting two families
of patents. One family relates to innovations that control the edge
characteristics of certain types of contact lenses. The second family
of patents relates to novel designs for certain types of contact
lenses, including certain types of toric lenses used to treat
astigmatism, the blurring of vision due to an irregularity in the
shape of the cornea.
CooperVision also filed suit, on April 11, 2006, against CIBA
Vision in federal district court in Wilmington, Delaware. CooperVision
seeks a judicial declaration that its Biofinity(tm) line of silicone
hydrogel contact lenses does not infringe certain CIBA Vision patents,
United States Patent Nos. 5,760,100, 5,776,999, 5,789,461, 5,849,811,
5,965,631 and 6,951,894. The CIBA Vision patents generally relate to a
type of silicone hydrogel lens.
CooperVision manufactures and markets contact lenses and ophthalmic
surgery products. Headquartered in Lake Forest, Calif., it
manufactures in Albuquerque, N.M., Juana Diaz, Puerto Rico, Norfolk,
Va., Rochester, N.Y., Adelaide, Australia, Hamble and Hampshire
England, Ligny-en-Barrios, France, Madrid, Spain and Toronto. Its Web
address is
www.coopervision.com.
CONTACT: The Cooper Companies, Inc.
Norris Battin
888-822-2660
Fax: 949-597-0662
ir@coopercompanies.com
|
|
Bausch & Lomb girds for solution-related losses
Healthcare products company also faces accounting issues; will not meet its
10-k filing deadline.
April 12, 2006: 5:20 PM EDT
CHICAGO (Reuters) - Bausch & Lomb set out Wednesday
to assuage investor fears as retailers began pulling one of its contact lens
solutions from shelves amid a U.S. government investigation over whether it is
linked to a serious eye infection.
U.S. health authorities are looking into 109 cases of Fusarium
Keratitis, a rare but serious eye infection that could cause permanent vision
loss if left untreated.
Twenty six of those patients said they had used Bausch & Lomb products or
generic versions made by the company. Bausch & Lomb Monday said it would stop
shipping its ReNu with MoistureLoc solution in the United States, but did not
issue a recall.
Executives from the eye care company, speaking on a conference call to the
investment community, said they cannot predict the sales impact on ReNu with
MoistureLoc, which had U.S. sales of roughly $45 million in 2005.
Major retail chains such as
Wal-Mart Stores Inc.
(Research)
and Walgreen Co.
(Research)
said they were removing the product from store shelves. Walgreen took the
added measure of removing all products under the ReNu brand.
"There's a lot of customer confusion out there, which is why we decided to
remove the entire ReNu line," a Walgreen spokesman told Reuters.
Shares of Bausch
and Lomb (Research)
fell 5.3 percent to $46.44 in Wednesday morning trade on the New York Stock
Exchange, after touching a three year low Tuesday.
"We have not begun to estimate the ripple effect this will take on other
ReNu products," said Ronald Zarrella, the company's chairman and chief
executive.
Zarrella told analysts the company will start an aggressive brand-building
campaign to help contain the impact of the problems, but the damage may have
already be done.
"I think this hurts their brand a great deal," said cornea specialist Dr.
David Ritterband of the New York Eye and Ear Infirmary, in a conference call
Wednesday sponsored by Banc of America Securities. "I don't know whether they
are going to shake it."
The company may already have to mend fences with some of its retail
customers. Banc of America analyst David Maris, in a research note, said that
the company had indicated Tuesday it had no plans to accept product returns
from retailers.
"We predict Bausch & Lomb will reverse this decision in a small attempt to
placate an upset trade channel," Maris wrote in a Wednesday report.
10k delays continue
The FDA said Monday it was not aware of a direct link between the infection
and any specific product.
But the infection concerns heap new pressure on Bausch & Lomb, which has
been plagued by accounting problems. Last month the company said it would
delay filing its 2005 annual report by six weeks until around April 30 to make
adjustments following internal investigations at foreign subsidiaries.
Zarrella Wednesday said the company would not meet that April deadline, but
would not elaborate on the reasons, a move Harris Nesbitt analyst Joanne
Wuensch in a research note called "somewhat disconcerting."
She maintained her "neutral" rating on the stock.
"Amidst all the activity around ReNu, the accounting issues continue to be
a meaningful risk in our view, and should not be ignored by investors," JP
Morgan analyst Michael Weinstein wrote in a research note. He estimated a new
filing deadline of May 31.
Concern about an increased incidence of the infection among users of Bausch
& Lomb products first arose in Singapore, where authorities linked a number of
cases of the infection to ReNu products. Hong Kong officials have asked Bausch
& Lomb to pull ReNu from shelves, but the company has said testing has not
shown a problem.
Bausch & Lomb said Wednesday the problems in the United States do not
affect other markets. There are no reported incidents of fungal eye infections
in Europe or China, and the company has been in contact with health
authorities in those regions, executives said.
Bausch & Lomb's robust contact lens and lens solution business had helped
to double the company's share price since July 2002.
The company last month said the issues with ReNu would reduce first-quarter
vision care revenue in the Asia region by as much as $10 million versus
internal expectations.
Concerns in Asia have depressed sales in other markets, particularly China,
the company has said.
There are more than 35 million contact wears in the United States alone,
according to American Academy of Ophthalmology. The physician group is working
closely with the FDA and the CDC.
The US Marine Corps are now using
the patented OMS Micro Tint System in their optical departments instead of
the old fashioned, dirty and fuming lens tinting units. This will allow them
to produce better and faster tinted lenses in a cleaner environment.
March 14, 2006, 5:35PM
(PZ)
Oakley Agrees to Acquire The Optical Shop of Aspen
14 Retail Locations
Cater to Luxury Eyewear Market
© 2006 PRIMEZONE
FOOTHILL RANCH, Calif., March 14, 2006 (PRIMEZONE) --
Oakley, Inc. (NYSE:OO) today announced it has signed a definitive agreement to
acquire all of the outstanding stock of privately held OSA Holding, Inc. and
its wholly owned subsidiary, The Optical Shop of Aspen (OSA), one of the
world's most respected retailers of luxury eyewear. Included in this
acquisition are The Optical Shop of Aspen's 14 retail locations.
"Oakley has established a renewed focus on optics and
is implementing strategies to build business platforms for sustainable growth
and profitability," said Scott Olivet, chief executive officer, Oakley, Inc.
"The Optical Shop of Aspen, along with our recent acquisition of Oliver
Peoples, strengthens our premium eyewear platform. In addition, OSA will help
build Oakley's prescription eyewear business and further develop the company's
retail capabilities."
"OSA is one of the country's most prestigious optical
retail chains, known for its unique first-class products and exceptional
service," said Cos Lykos, vice president of business development, Oakley, Inc.
"This acquisition provides us with direct access to the premium eyewear
consumer and we are very excited to add The Optical Shop of Aspen's premier
eyewear destinations to our retail lineup."
"For more than 30 years we have cultivated a loyal
consumer following based on innovative eyewear collections, outstanding
customer service and unique retail environments," said Larry Sands, founder
and chief executive officer, The Optical Shop of Aspen. "I am passionate about
the success of our business. I care about my employees, their future and the
future of this brand. I am confident this partnership will help elevate OSA to
new heights and allow us to realize the significant opportunities before us."
The Optical Shop of Aspen currently has 14 retail
stores located in Arizona, California, Colorado, Florida, New Mexico and
Missouri, and will operate as a wholly owned subsidiary of Oakley, Inc. After
the completion of the merger, Sands will continue as chief executive officer
of OSA and maintain independent ownership and operation of OSA International,
a separate wholesale company.
Specific terms of the agreement were not disclosed. The
company expects the acquisition to be closed during the second quarter of
2006. Oakley expects the acquisition to be slightly accretive to earnings in
2006.
About The Optical Shop of Aspen
Headquartered in Aliso Viejo, CA, The Optical Shop of
Aspen was founded in 1970 by Larry Sands who sought to define eyewear as a
high-end fashion accessory. The Optical Shop of Aspen stocks its stores with
innovative, high-end labels such as Cartier, Chanel, Christian Dior, Chrome
Hearts, Oakley, Oliver Peoples and Paul Smith. Optical Shop of Aspen
International, the company's wholesale division, designs, distributes and owns
the licenses to the Blinde, Chrome Hearts, Hiero, Kieselstein-Cord and Matsuda
eyewear brands. Under the direction of Optical Shop of Aspen International's
in-house design team, each collection pushes the boundaries of technology and
style, further bringing the concept of 'luxury' to eyewear. For more
information on OSA's retail stores and eyewear collections, please visit
http://www.osainternational.com/web/top/index-corp-top.html.
Essilor Total Aquisitions 2005...........
Press Release.. March 9, 2006
ACQUISITIONS
Essilor pursued its external growth in 2005, enhancing its positions in
prescription laboratories and finished-lens distribution. In all, 18
companies were acquired in 2005 for a total €115.7 million. The full-year
sales of these acquisitions represented around €92 million.
Three transactions were completed in Europe during the year:
-
<LI cursize="1">The acquisition of ATR Mec Optical, the Italian
distributor of Essilor subsidiary BBGR. ATR Mec owns two prescription
laboratories. <LI cursize="1">The acquisition of OMI, Essilor’s
exclusive lens distributor in Martinique, Guadeloupe and French Guiana. OMI
has a prescription laboratory in Guadeloupe.
-
The acquisition of a 25% stake in Ayudas para la Vision Subnormal (AVS),
a company based in Madrid, Spain that manages a visual rehabilitation center
for people suffering from visual deficiency. This transaction will enable
Essilor and AVS to develop services for the visually impaired.
Essilor made nine acquisitions in the United States:
-
<LI cursize="1">The Spectacle Lens Group, the ophthalmic lens
business of Johnson & Johnson Vision Care Inc., a subsidiary of US-based
Johnson & Johnson. The transaction was approved by US antitrust authorities
and completed in the third quarter of 2005. Created in 1999, The Spectacle
Lens Group has developed the Definity™ brand of progressive lenses,
featuring unique Dual Add™ technology that divides progressive add power
between the front and back surfaces.
Definity™ was introduced in select US test markets in late 2002 ands is well
respected among local eye care professionals consumers.
The acquisition is fully in line with Essilor’s strategy of offering
innovative, high value-added products.
The Dual Add™ and related technologies will enhance the Company’s research
programs to improve and personalize its offering of progressive lenses.
-
The industrial and marketing assets of National Optronics, based in
Charlottesville, Virginia. Founded in 1979, National Optronics designs and
manufactures precision edging systems, primarily for prescription
laboratories, based on its specific technology. National Optronics has
consolidated Essilor’s position as the worldwide leader
