Bausch & Lomb removes contact lens-solution linked to infections

Last update: May 15, 2006 - 9:18 AM

ROCHESTER, N.Y. Bausch & Lomb Inc. said today it has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness.

"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products,'' said the eye-care product maker's chief executive, Ronald Zarrella.

The Centers for Disease Control and Prevention said Friday that 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 Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure,'' Zarrella said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances,'' he said. "We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula.

"We are taking this action even in countries where we have seen no unusual trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa,'' he added.

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.

Bausch & Lomb also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments and generates more than $2 billion in annual revenues. The company has not issued guidance for 2006 and said it cannot estimate how the recall will affect results this year.

The fallout has helped to undermine its stock, which peaked at $87.89 in July after more than two years of robust growth. Its shares, which have sunk 35 percent this year, rose 18 cents to $44.62 in morning trading on the New York Stock Exchange. The company employs 12,400 people worldwide.

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