FDA warns company after eye infections
Washington, D.C. ? 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, according to a federal warning letter.
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 Food and Drug Administration said in the letter. The reporting failure occurred after the company suspended sales of its ReNu with MoistureLoc solution in Singapore.
It also came after the FDA started an investigation of the Greenville, S.C., manufacturing plant where Bausch & Lomb made the now-withdrawn MoistureLoc solution.
Bausch suspended sales of MoistureLoc in Singapore and Hong Kong in February and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the brand of solution was the potential “root cause” of increased risk of the fungal infection, called Fusarium keratitis.




