FDA Wants Contact Lens Solutions To Go Through Stringent Test Standards

Contact lens solutions may have to undergo stringent tests keeping in view the numerous eye infections associated with them, say U.S. regulators.

Many proposals have been considered by the Food and Drug Administration which are intended to improve the quality and safety standards of these solutions.

New testing standards will be evaluated and outlined by the agency, including descriptive labeling recommending users that they rub the lens gently.

There are several solutions to be found over-the-counter including multipurpose solutions. Bausch & Lomb came under the scanner after launching its new solution named Advanced Medical Optics due to eye infection epidemic and later had to recall the solution.

Bausch & Lomb's MoistureLoc solution was found to trigger 180 Fusarium keratitisdefine fungal infections, which is serious and can cause blindness, according to The Center for Disease Control and Prevention report of year 2006.

Bausch & Lomb is negotiating with FDA for quite some time over issuing safe usage directions on their solution, Renu Multiplus. This solution carries a label that does not recommend users to rub their lenses. But doctors say that rubbing keeps lenses clean and free of any build-up. A panel of experts from FDA will be deciding if this recommendation should be printed as a requirement.

Bausch & Lomb spokesperson Michael McDougall said "We felt that if the solution was effective enough to pass FDA's stringent requirements without rubbing then consumers should get that benefit, but should FDA decide a rub requirement is necessitated, we would have no problem with that."

Recently, a "rinse and rub" instruction was added to Advanced Medical Optics' latest solution as it entered market again after reformulation. Similar solutions from Alcon Inc. and other manufacturers bear a "no rub" instruction on their labels.

CDC associated Complete Moistureplus solution from Advanced Medical Optics' to unusual bacteria called Acanthamoeba keratitis, which is said to infect the eye. It is not listed by FDA in the bacteria and fungi list, against which the solutions are to be tested. Hence, panel of eye experts will argue on the issue of testing these products against a wide spectrum of bacteria.