updated 4/19/2006 5:29:46 PM ET 2006-04-19T21:29:46

The optical solutions plant at the center of a probe into several cases of eye fungus was cited by the federal Food and Drug Administration for quality-control problems in 2002.

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Last week, Rochester, N.Y.-based Bausch & Lomb stopped shipment of its contact lens solution, Renu with MoistureLoc, while federal health officials try to determine if the solution is linked to more than 100 cases of eye fungus.

During inspections in May and June 2002 at Bausch & Lomb’s Greenville, S.C., plant, the FDA discovered paint chips in rooms where containers of eye care products were filled. The FDA said the company failed to adequately investigate the cause of the paint chips “which directly related to product quality,” according to a warning letter dated July 17, 2002.

The warning letter also raised concerns about the plant’s ability to test for the appropriate amount of preservative/disinfectant “used in the majority of your eye care products.”

“The specific violations noted in this letter ... could be symptomatic of serious underlying problems in your firm’s quality system,” said the letter, signed by Ballard Graham, director of the FDA’s Atlanta district at the time.

The Atlanta Journal-Constitution, which first reported the inspections in Wednesday’s editions, said the Greenville plant passed inspection in March 2003 and was not reinspected until last month, after the first cases of eye fungus were reported.

Renu with MoistureLoc wasn’t manufactured until 2004.

A spokeswoman for the FDA did not return calls seeking comment Wednesday afternoon.

Company says problem was fixed
Meg Graham, director of corporate communications for Bausch & Lomb, said the warning letter only reflected a problem with the way the company documented the paint chip problem. The company discovered the paint chips during a routine plant inspection and remedied the problem, she said.

“It’s erroneous that the FDA found paint in the place and ordered us to clean it up,” she said. “The real story is that there were these flecks of paint found by Bausch & Lomb that were remedied.

“The quality and sterility of the products made there was never in question,” Graham said.

The fungus, Fusarium keratitis, is commonly found in plant material and soil in tropical and subtropical regions. Without eye drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims.

U.S. retailers, led by Wal-Mart Stores Inc., Walgreen Co. and CVS Corp., pulled the solution off their shelves last week and two optician chains in Scandinavia followed suit.

The company stopped shipments of MoistureLoc in the United States last week when the Centers for Disease Control and Prevention revealed it was scrutinizing 109 reports of Fusarium keratitis infections in patients in 17 states.

Federal health officials have made no direct link between MoistureLoc and the infections, but a high incidence of the dozens of affected patients interviewed so far had used the cleaner.

More than 30 million Americans wear contact lenses, and analysts estimate that nearly 10 million of them use Bausch & Lomb lens care solutions.

Lawsuits have been filed in New York and Florida over the infections.

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