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.
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.
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SOURCE: Bausch & Lomb