Failure to Prevent Potential Contamination by Bausch & Lomb Draws Sharp Criticism From The FDA
Posted by
Robert WolfMay 18, 2006 9:54 AMBausch & Lomb failed to notify United States regulators within 30 days about 35 serious bacterial infections reported in Singapore in users of its ReNu with MoistureLoc contact lens solution, the Food and Drug Administration said in a report released on Tuesday. The finding was among 20 observations of potential violations the F.D.A. listed after inspecting Bausch & Lomb plants in Greenville, S.C.
The F.D.A. report came a day after the company permanently withdrew ReNu With MoistureLoc from the market -- expanding an earlier recall -- because the product may increase the risk of a fungal eye infection that can result in blindness.
The FDA also stated that Bausch & Lomb did not notify it in writing that it had withdrawn the solution from sale in Singapore and Hong Kong in February. According to the report posted on the F.D.A.'s Web site, Bausch & Lomb failed, as well, to follow proper procedures to prevent contamination of equipment at the plant.
A spokeswoman for the company, Meg Graham, said in a statement that it was working with the F.D.A. to address its observations.
Bausch's chief executive, Ronald L. Zarrella, said Monday that the costs associated with the recall would be $50 million to $70 million. The company is also facing about $100 million in lost ReNu sales and will presumably have to spend on marketing to recover market share.
According to an article in the New York Times, executives initially thought that the infection might have been linked to contamination at its plant in Greenville. But the F.D.A., which found manufacturing problems not connected with the outbreak, said the cases appeared to be related to the design and use of the ReNu With MoistureLoc formula.
Last month, Bausch & Lomb withdrew the product in the United States after it was linked to a number of the fungal infections. The recall now extends to regions where the company has seen no unusual trends in these infections, including Europe, the Middle East, Africa and China.
The F.D.A. said data so far did not indicate problems with Bausch & Lomb's ReNu MultiPlus or ReNu Multi-Purpose brands. MultiPlus, though, has been linked with the fungal infection in reports by the Centers for Disease Control and Prevention.