Bausch & Lomb Recalls MoistureLocTM Worldwide
AUCKLAND May 16. /MediaNet International-AsiaNet/ -- Customer Safety is Our Top Priority, Says CEO
Bausch & Lomb (NYSE:BOL) announced today that it is permanently recalling its MoistureLocTM contact lens solution from worldwide
markets effective immediately.
The product is NOT available in New Zealand and there has been NO unusual trend in the incidence of Fusarium keratitis
in New Zealand where ReNu® MultiPlus® is currently marketed, the brand more people worldwide have chosen for their
contact lens care. This product has longstanding unsurpassed records of safety and effectiveness, and has a formula
different from that of MoistureLocTM.
Manufacturing plants in Greenville, S.C., United States; Milan, Italy; Beijing, China; and Bhiwadi, India, will shift
production from MoistureLocTM to the ReNu® MultiPlus® and ReNu® Multi-Purpose formulas.
“Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products.” said
Bausch & Lomb Chairman and CEO Ronald L. Zarrella.
Health authorities in Hong Kong, Singapore and the United States previously reported that the MoistureLocTM formula was
used by many of the contact lens wearers treated for a rare eye infection called Fusarium keratitis. Bausch & Lomb immediately launched a massive investigation to determine the root cause of the infections and to understand why
there appeared to be a disproportionate association with MoistureLocTM. Because the product sold in those markets was
made in the company’s Greenville, S.C. factory, Bausch & Lomb initially removed the MoistureLocTM product from markets suppl
ied by that plant.
“After an extensive investigation involving thousands of tests, millions of dollars and collaboration with government
agencies, health authorities and independent experts, there is no evidence of product contamination, tampering,
counterfeiting or sterility failure,” Zarrella said. “That leads us to conclude that some aspect of the MoistureLocTM
formula may be increasing the relative risk of Fusarium infection in unusual circumstances. We are continuing to
investigate this link, but in the meantime, we’re taking the most responsible action in the interests of our customers
by discontinuing the MoistureLocTM formula. We are taking this action even in countries where we have seen no unusual
trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa.”
The FDA and the U.S. Centers for Disease Control and Prevention previously reported that MoistureLocTM solution was
disproportionately represented among the confirmed cases of Fusarium keratitis, as compared with other Bausch & Lomb or competitive products.
Whilst New Zealand is NOT affected by this action, if consumers have further concerns they should consult their eye
care practitioner.
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About Bausch & Lomb
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its
core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and
pharmaceutical products.
The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is
headquartered in Rochester, New York. Bausch & Lomb’s 2004 revenues were $2.2 billion; it employs approximately 13,700 people worldwide and its products are available
in more than 100 countries. More information about the Company is on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb Incorporated.
This news release contains, among other things, certain statements of a forward-looking nature relating to future
events or the future business performance of Bausch & Lomb.
Such statements involve a number of risks and uncertainties including, without limitation, those concerning global and
local economic, political and sociological conditions; currency exchange rates; government pricing changes and
initiatives with respect to healthcare products; changes in laws and regulations relating to the Company's products and
the import and export of such products; product development and rationalization;
enrollment and completion of clinical trials; the ability of the Company to obtain regulatory approvals; the impact of
the matters described in this news release on sales of the Company’s other lens care products or other products, the
cost to the Company of recalling product, defending matters in litigation, investigations and future product testing and
other related costs and expenses; the outcome of the Audit Committee’s continuing independent investigations of events
described in the Company’s prior disclosures concerning those investigations;
the outcome of PriceWaterhouseCoopers’ quarterly review process in connection with the filing of the Company's Quarterly
Report on Form 10-Q for the third quarter of fiscal 2005 and of the extended year-end review process in connection with
the filing of the Company’s Annual Report on Form 10-K for fiscal 2005 and the expected, estimated adjustments described
in this news release; the filing of the Company's 10-Q for third quarter of fiscal 2005 and its 10-K for fiscal 2005;
the possibility that the market for the sale of certain products and services may not develop as expected; the financial
well-being of key customers, development partners and suppliers; the successful execution of marketing strategies;
continued efforts in managing and reducing costs and expenses;
the successful completion and integration of business acquisitions; the Company’s success in introducing and
implementing its enterprise-wide information technology initiatives, including the corresponding impact on internal
controls and reporting; the Company's success in the process of management testing, including evaluation of results;
continued positive relations with third party financing sources and the risk factors listed from time to time in the
Company’s SEC filings, including but not limited to the Current Report on Form 8-K, dated June 14, 2002 and the Form
10-Q for the quarter ended June 25, 2005.
®/™ denote trademarks of Bausch & Lomb Incorporated.
SOURCE: Bausch & Lomb
ENDS