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HK Told Bausch & Lomb of Eye Infections in Sept

April 27, 2006

NEW YORK/HONGKONG — Hong Kong’s government said on Thursday it alerted Bausch & Lomb Inc. to eye infections in users of its contact lens solution in September 2005, way before the company withdrew its product in February this year.

Hong Kong’s Health Department tested samples of the solution after it noticed four cases of microbial keratitis in July and August 2005, a government spokeswoman said on Thursday. Keratitis is inflammation of the cornea.

“We contacted Bausch & Lomb in September and we tested samples of its solution but we found nothing,” she said. It was not clear if the tests were done before or after the government contacted the company.

But the problem came to the fore again when Hong Kong’s government noticed cases of fungal corneal infections involving users of the solution in Singapore in early 2006.

“We talked to Bausch & Lomb again in February (2006) and it voluntarily withdrew its product,” the spokeswoman said.

Between June 2005 and January 2006, there were between 2 to 3 cases of fungal keratitis each month in Hong Kong, she added.

Bausch & Lomb could not immediately be reached in Hong Kong for comment.

The Wall Street Journal reported on Thursday that Bausch & Lomb was alerted by Hong Kong health officials to eye infections in users of its contact lens solution in November 2005.

The company reported the cases to the U.S. Food and Drug Administration (FDA), which was informed of the problem by Hong Kong authorities in December, but the company’s report said that “no causal factors can be determined and no conclusion can be drawn,” the Journal said.

FDA officials said this month that the company’s contact lens solution was currently under inspection by the agency, which could take up to a month.

U.S. health authorities are looking into more than 100 cases of a rare fungal infection that can cause permanent vision loss if left untreated.

This month, Bausch & Lomb stopped shipping the solution, called ReNu with MoistureLoc, and urged retailers to pull it from shelves.


Source: reuters



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