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Bill would regulate non-corrective lenses as medical devices
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WASHINGTON — Federal legislation has been introduced that would require the Food and Drug Administration to regulate plano contact lenses as medical devices.
The bill, HR 2218, was introduced by Rep. John Boozman (R-Ark.) and Rep. Henry Waxman (D-Calif.) within weeks of the FDA’s controversial decision to regulate these lenses as cosmetics.
According to American Optometric Association President J. Pat Cummings, OD, contact lenses that are improperly manufactured or are used without appropriate medical supervision can cause serious eye infections and loss of vision.
“The FDA has historically and correctly classified plano or ‘zero power’ contact lenses as prescription devices, because it is necessary for an eye care practitioner to evaluate the ocular health of the patient and the fit of the lens to the eye, just as they would for lenses with power,” said Dr. Cummings in an AOA press release.
Non-corrective, color contact lenses have reportedly been sold in locations such as beauty salons, flea markets and gas stations across the country. Eye care practitioners have called attention to a number of serious injuries, especially among young people who may not be informed on the proper care and use of contact lenses.
The organizations supporting Reps. Boozman and Waxman’s bipartisan effort include the AOA, the American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, Prevent Blindness America and the Contact Lens Institute.