FDA Cites Bausch & Lomb for Not Reporting Tainted ReNu with MoistureLoc
Bausch & Lomb Inc. failed to formally report nearly three dozen foreign cases of fungal eye infections later linked to one of its contact-lens solutions.
Bausch & Lomb didn't report the 35 serious injury reports by April 7, as required by law, after Singapore health officials had alerted the Rochester, N.Y., company. The reporting failure occurred after the company had suspended sales of its ReNu with MoistureLoc solution in Singapore.
Bausch & Lomb suspended sales of MoistureLoc in Singapore and Hong Kong in February 2006 and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the solution was the potential cause of increased risk of the fungal infection. (Source: ReNu Recall News)
