FDA panel recommends stricter labeling for eye care products

6/23/2008

GAITHERSBURG, Md. A Food and Drug Administration advisory panel on June 10 recommended there be stricter labeling and testing for contact lenses and cleaning solutions, following a meeting of the Ophthalmic Device Panel of the Medical Devices Advisory Committee.

The meeting was called by the FDA, in part, because of the number of product recalls associated with contact lens cleaning solutions in the past few years.

Specifically, the advisory committee suggested stronger label warnings that would identify potential infections that can lead to blindness, for example, as a possible consequence of not following product instructions. 

Panelists also recommended the agency require pre-approval testing of the efficacy of lens solutions against Acanthamoeba keratitis, a parasite involved in one of the outbreaks. 

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