WASHINGTON, May 17 (Reuters) Bausch&Lomb Inc failed to promptly tell US regulators about 35 serious eye infections reported in Singapore in users of its now-withdrawn contact lens solution, the Food and Drug Administration.
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 yesterday to 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.
On March 27, ''clean, uncapped product transfer hoses that are used in production were observed in direct contact with a shelving unit upon which a visible layer of a white powdery residue was observed,'' the report said.
Health officials initially thought the infection may have been linked to potential contamination at the Bausch plants.
Preliminary results from a variety of manufacturing, environmental and other tests ''have not found that these factors have contributed to Fusarium contamination,'' the FDA statement said.
Company spokeswoman Meg Graham, in a statement, said the company is working with the FDA to address its observations.
Bausch CEO Ronald Zarrella said on Monday that the costs associated with the recall would range from 50 million dollars to 70 million dollars. Bausch also faces about 100 million dollars in lost sales and will need to spend on marketing to recover lost market share.
One analyst estimated that potential liability from the infection outbreak could rise into the 500 million dollars to 1 billion dollars level.
The FDA has said data so far did not indicate problems with the Bausch's ReNu MultiPlus or ReNu Multi-Purpose brands.
MultiPlus, however, has also been linked with the fungal infection in reports by the US Centers for Disease Control and Prevention.
Bausch shares closed down $1.37, or 2.7 per cent, at $48.71 on the New York Stock Exchange.
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