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Bausch & Lomb Inc. failed to promptly tell U.S. regulators about 35 serious eye infections reported in Singapore in users of its now-withdrawn contact lens solution, the Food and Drug Administration said in a report released on Tuesday.
The company also did not notify the agency in writing that it had pulled the solution from Singapore and Hong Kong in February, the FDA said in a report of an inspection seeking clues to an outbreak of potentially blinding fungal eye infections known as Fusarium keratitis.
Bausch & Lomb has said the formulation of its ReNu with MoistureLoc contact lens solution may be the root cause of the infections. The FDA has agreed and supported the company's announcement on Monday that it was permanently withdrawing the product worldwide.
Inspectors said Bausch & Lomb failed to tell the FDA within the required 30 days about 35 serious injuries from Fusarium keratitis reported in Singapore in February. "None of the complaints were reported to the agency as of April 7, 2006," the inspectors said.
The FDA inspection report listed 20 potential violations at Bausch & Lomb facilities in Greenville, South Carolina.
The findings, which the FDA called preliminary, also detailed peeling paint, powdery residue and other poor manufacturing practices that the agency said may not be related to the infections.
"It is premature to conclude that some of the observations cited in the report are associated with the cases of Fusarium keratitis," an FDA statement said.
On April 19 "in the upper mix room, peeling paint and paint chips were observed on agitators located on the tops of tank(s)... currently used for the production of contact lens solution," FDA inspectors wrote.