Pharmabiz
 

Bausch & Lomb voluntarily recalls MoistureLoc worldwide

Rochester, New YorkTuesday, May 16, 2006, 08:00 Hrs  [IST]

Bausch & Lomb is permanently removing its MoistureLoc contact lens solution from worldwide markets effective immediately. "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 MoistureLoc 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 understand why there appeared to be a disproportionate association with MoistureLoc. Because the product sold in those markets was made in the company's Greenville, SC factory, Bausch & Lomb initially removed the MoistureLoc product from markets supplied 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 MoistureLoc 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 MoistureLoc 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," he added. The FDA and the US Centres for Disease Control and Prevention previously reported that MoistureLoc solution was disproportionately represented among the confirmed cases of Fusarium keratitis, as compared with other Bausch & Lomb or competitive products. Bausch & Lomb suggests that former MoistureLoc users switch to ReNu MultiPlus or ReNu Multi-Purpose, the brands more people worldwide have chosen for their contact lens care. Bausch & Lomb introduced the MoistureLoc formula in late 2004. The product contributed approximately $100 million of sales in 2005.

 
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