FDA takes hard look at contact lens fluid

Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the last two years.

The Food and Drug Administration outlined several proposals Friday aimed at improving the safety of solutions used by as many as 34 million Americans who wear contact lenses.

Specifically, the FDA is considering new testing standards for contact solutions and updated labeling, including recommending that users gently rub their lenses during the cleaning process.

On Tuesday, the agency will ask a panel of outside experts to weigh in on the ideas.

Multipurpose solutions have been on the market for a decade, all but replacing older systems that use several formulas to rinse and clean contacts.

But the effectiveness of newer solutions has been questioned since Bausch & Lomb Inc. and Advanced Medical Optics Inc. separately pulled their products off the market in 2006 and 2007 after eye infection outbreaks.

The Centers for Disease Control and Prevention concluded in summer 2006 that Bausch & Lomb’s MoistureLoc solution played a key role in an outbreak of 180 Fusarium keratitis fungal infections, which can cause blindness.

A Bausch & Lomb spokesman said the company had been in discussions with the FDA for more than a year to ensure that its remaining solution, Renu Multiplus, is used safely.

Like most other products on the market, Renu’s labeling does not advise patients to rub their contacts, an instruction that some eye doctors say helps keep lenses clean. The FDA will ask its panel of eye care experts whether the recommendation should be a requirement.

If the government favors that action, Bausch & Lomb said it would comply.

Panelists also will debate whether contact solutions should be tested against a wider variety of bacteria.