- The Washington Times - Thursday, April 27, 2006

ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc., which recently halted U.S. sales of a contact lens cleaner linked to an apparent outbreak of a severe fungal eye infection, said yesterday it was alerted in the fall to a rise in infections among lens wearers in Hong Kong.

The eye-care products maker suspended shipments of its ReNu with MoistureLoc solution in the United States on April 10, when the Centers for Disease Control and Prevention revealed it was scrutinizing a flurry of Fusarium keratitis infections in Americans using the product.

U.S. health officials have found no direct link between MoistureLoc and the infections. But a high incidence of the affected patients interviewed so far had used the brand, which hit stores in late 2004 and contains new-generation moisturizing and conditioning agents.

Without eye-drop treatment, the infection can scar the cornea and blind its victims. At least eight persons have required cornea transplants.

Bausch & Lomb said it cut off shipments to the Far East in February after “an unusual spike” in the rate of lens-related keratitis infections in Singapore. That discovery prompted Hong Kong authorities to reopen an earlier investigation into infections that had been cropping up since June 2005, the company said.

Hong Kong health officials told Bausch & Lomb in November they had seen an increase in hospital admissions because of lens-related keratitis infections, spokeswoman Meg Graham said. But investigations by both Hong Kong and company officials found no cause-and-effect link to MoistureLoc, she said.

“We looked into it, they looked into it, and as far as we know, the case was closed and this was just considered to be some sort of an aberrational occurrence,” Ms. Graham said.

When the Singapore Ministry of Health notified the company Feb. 18 it had recorded dozens of lens-related keratitis infections, Hong Kong “decided to go back and take a look at some of the data that it had in that earlier investigation,” she said.

Hong Kong officials said they had interviewed 62 patients, of whom 25 said they had used a ReNu solution. Seven of those 25 patients had the Fusarium keratitis infection, Ms. Graham said.

Bausch & Lomb reviewed its manufacturing and testing data and turned over a report of its investigation to Hong Kong, but “no additional questions or clarifying requests” were made at the time, she said.

The company filed reports of the 25 cases with the U.S. Food and Drug Administration in December. The reports said “no causal factors can be determined and no conclusion can be drawn,” she said.

The number of suspected or confirmed cases of the infections in the United States has risen to 186 in 29 states, up from 109 cases reported April 9, the Centers for Disease Control and Prevention said yesterday. Of the 186 cases, 73 have been confirmed, but the CDC won’t say how many patients had used a ReNu solution.

The CDC and FDA agencies said it could take a month to determine if MoistureLoc was the cause of the infections. Inspectors have been combing the Greenville, S.C., plant where the solution is made for Far East and U.S. markets, and extensive microbiological tests could take weeks to analyze.

Symptoms can include blurry vision, pain or redness, excessive discharge and increased sensitivity to light.

MoistureLoc generated $45 million in U.S. sales last year. More than 30 million Americans wear contact lenses, and analysts estimate that nearly 10 million of them use Bausch & Lomb lens care solutions.

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