Bausch & Lomb failed to submit a medical device report (MDR) detailing 35 serious injury reports of Fusarium keratitis -- the most common form of fungal keratitis, an infection of the cornea -- in contact lens wearers using the firm's ReNu with MoistureLoc product in Singapore, the FDA said in a Form 483 issued to the company May 15.
Singapore's Minister of Health reported the incidents to the company in February, but none of the complaints had been reported to the FDA as of April 7, the agency said. Five other complaints of Fusarium infection were reported to the firm in July 2005 but had not been reported to the agency as of May 9. The firm also did not report its removal of ReNu with MoistureLoc or its Multi-Purpose solution from the market in Singapore and Hong Kong in February.
The company has been subject to a number of lawsuits from people claiming injury from the product. A New York man filed a lawsuit against Bausch & Lomb in federal court April 20, accusing the company of engaging in deceptive marketing practices and failing to publicly disclose an inherent defect in its ReNu with MoistureLoc solution that makes the product susceptible to Fusarium keratitis. Nelson Huie has alleged the company knew of the link between the product and increased incidences of Fusarium in Asia as early as February, but did not suspend sales of the product in the U.S. until cases of the infection became public.