- The Washington Times - Monday, May 15, 2006

ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc. has permanently withdrawn a new formula contact-lens cleaner viewed as the “potential root cause” of a far-flung outbreak of fungal eye infections known to cause blindness. Its stock, hit hard over the past month, rose nearly 12 percent.

The Food and Drug Administration said yesterday that the eye care company thinks ReNu with MoistureLoc’s unique disinfecting and moisturizing agents “in certain unusual circumstances can increase the risk” of developing Fusarium keratitis, adding that the way some people used the solution may have contributed.

“Based on the understanding we have now, there are a large number of factors that sort of have to come together for this to come into play,” said Dr. Daniel Schultz, director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. “That is what makes this more different than your average user-error scenarios.”

The company suspended U.S. sales of MoistureLoc on April 13 after the Centers for Disease Control and Prevention (CDC) said it was investigating a spike in infections in Americans using the product. The outbreak first surfaced in the Far East, leading to a halt in sales in Singapore, Hong Kong and Malaysia on Feb. 18.

The fungus is commonly found in plant material and soil in tropical and subtropical areas, with strains often showing up in sinks, drains or bathrooms where people handle their lenses. Without treatment, which can last two to three months, the infection can scar the cornea and blind its victims.

The sharp rise in infections brought a flurry of product-liability lawsuits. One woman in Florida reported that the solution caused her to lose an eye, and at least eight other persons underwent cornea transplants.

“Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products,” Chief Executive Officer Ronald Zarrella said in announcing that MoistureLoc was being removed immediately from markets worldwide.

The CDC said the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using MoistureLoc.

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