Recall Appears to Have Ended Spread of Eye Disease

Bausch & Lomb Inc.’s global recall of a popular contact lens solution in May appears to have stopped the spread of a serious eye infection, but U.S. scientists still do not know what caused the outbreak, according to a study released Tuesday.

Researchers at the U.S. Centers for Disease Control and Prevention found no infectious agent in the Bausch & Lomb solution but do not believe improper lens hygiene practices by consumers alone are enough to explain the outbreak of the Fusarium keratitis infection, which in some cases required a cornea transplant.

“We feel pretty confident that the outbreak is over,” said CDC researcher Benjamin Park, who has studied the outbreak since the first reports of the infection in the U.S. in early March.

The rare but potentially blinding fungal infection prompted Bausch & Lomb to halt shipments of its ReNu with MoistureLoc lens solution to U.S. retailers in April.

Bausch issued a global recall of the solution in May and this month slashed its 2006 earnings forecast.

Clusters of infection were first reported in Singapore and Hong Kong this year, and the product was pulled from those markets in February.

Park and colleagues at the CDC in Atlanta conducted a study to determine the specific activities, hygiene practices and products associated with the infection. The study appeared in the Aug. 23-30 issue of the Journal of the American Medical Assn.

As of June 30, the researchers had identified 164 confirmed cases of Fusarium keratitis. In 154, or 94%, of the cases, the patients wore soft contact lenses.

Infected patients came from 33 states and one U.S. territory, and about 34% of them required a corneal transplant.

According to the study, infected contact lens wearers were 20 times more likely to have used Bausch & Lomb’s ReNu with MoistureLoc lens solution than another solution.

The company faces a number of lawsuits because of the infection.

In addition to the loss of a $100-million-a-year product, analysts said, Bausch & Lomb faces $500 million to $1 billion in potential liability from the infection.

Bausch & Lomb has theorized that ingredients unique to the MoistureLoc solution could have formed a thin film on contact lens cases and the tip of bottles, rendering the solution less effective.

CDC researchers said that scenario was possible but needed more study.

Shares of Bausch & Lomb have fallen more than 31% since the beginning of the year.

Though some infected contact lens wearers reported having used another Bausch product, ReNu MultiPlus, Park said the incidence rate was not statistically significant.

The study, which looked at samples of the solution from the factory, the warehouse, returned bottles and other sources, concluded that the infection was not present in the solution but most likely came from external sources, such as the users’ homes.

Researchers said the fungus that caused the infection was common to tropical regions but also could be found in sink drains.

But the study said lax hygiene alone could not have caused the outbreak.