Tuesday, November 14, 2006

WSJ: FDA Warns Bausch & Lomb

Article in the Wall Street Journal -- FDA Warns Bausch & Lomb On Lens-Solution Infections, by Patricia Kowsmann:

Bausch & Lomb Inc. received a warning letter from the Food and Drug Administration, following an inspection of the company's Greenville, S.C., plant from March 22 through May 15. The inspection was in connection with reports that some users of Bausch & Lomb's ReNu with MoistureLoc contact-lens solution contracted a rare eye infection.

The Rochester, N.Y., company pulled the cleaning solution from world-wide markets in May after it said the product's formulation combined with certain use patterns likely contributes to an increased risk of Fusarium keratitis, a fungal eye infection that can lead to blindness.

The warning letter, dated Oct. 31 and addressed to company Chairman and Chief Executive Ronald L. Zarrella, reiterated preliminary findings the FDA reported in May. Like the preliminary report, the letter said the inspection didn't identify any conditions that contributed to or caused the infection, but it did find other problems.



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