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Home » FDA: Bausch & Lomb Did Not File Medical Device Reports for Fusarium Keratitis
FDA: Bausch & Lomb Did Not File Medical Device Reports for Fusarium Keratitis
June 1, 2006
Bausch & Lomb failed to submit a medical device report (MDR) detailing 35 serious injury reports from Fusarium keratitis in contact lens wearers using ReNu with MoistureLoc in Singapore, the FDA said in a Form 483 issued to the company May 15.