Bausch & Lomb Responsible

May 2006

After a voluntary recall of their ReNu with MoistureLoc lens cleaner worldwide, the Food and Drug Administration (FDA) is blaming Bausch & Lomb for the increase in the Fusarium keratitis eye infections.

According to an FDA report, Bausch & Lomb failed to notify them within 30 days of learning about 35 cases of severe eye infections in Singapore among users of their ReNu with MoistureLoc contact solution. Also, Bausch & Lomb did not give the FDA a written statement notifying them that they were taking the solution off the market in Singapore and Hong Kong. These are just two of the 20 potential violations the FDA listed after inspecting the Greenville, SC plant. Manufacturing problems were also found but not in connection with the outbreak.

The Centers for Disease Control and Prevention has confirmed 122 cases of the infection in the United States. The fungal eye infections, which can lead to blindness, appear to be related to the design and use of the MoistureLoc formula.

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