WASHINGTON – Academy-backed legislation regulating cosmetic plano contact lenses passed the Senate on July 29.  The bill, sponsored by Sens. Mike DeWine,  R-Ohio, and Edward Kennedy, D-Mass., amends the “Federal Food, Drug, and Cosmetic Act” to provide that all contact lenses shall be deemed to be medical devices. Similar legislation was introduced in the 108th Congress and passed the House unanimously, but was never brought to the Senate floor for consideration. A companion bill (H.R. 371), sponsored by Reps. John Boozman, R-Ark., and Henry Waxman, D-Calif, is poised for House consideration when Congress returns in September.

The Academy initiated efforts to regulate cosmetic plano contact lenses following several reports of teenagers who developed serious eye problems after using nonprescription cosmetic lenses purchased from flea markets, beauty parlors, gas stations and other unauthorized vendors.

“The Senate's passage of the plano lens bill is an important first step toward ensuring safety for all contact lens wearers," said Thomas L. Steinemann, MD, a member of the American Academy of Ophthalmology and associate professor of ophthalmology at Case Western Reserve University. "It doesn't matter why you wear contact lenses - to correct your vision or just for fun - the potential for risk to your eyesight is the same.  That's why all lenses must be properly dispensed and fit."

Dr. Steinemann, a constituent of Sen. DeWine, authored a case report of six patients treated for complications related to these lenses that appeared in the October 2003 issue of Eye & Contact Lens. Two of his patients developed blinding complications, requiring lengthy hospital stays. One 14-year-old patient needed a corneal transplant after wearing cosmetic lenses without the supervision of an eye care professional; the other patient remains legally blind. Dr. Steinemann recently documented another 11 cases, and three of those patients developed blinding complications requiring hospitalization.

After the Academy provided the Food and Drug Administration (FDA) with several cases detailing adverse affects, the FDA took action, ordering FDA and customs officials to detain decorative contact lenses presented at United States ports of entry that were intended for distribution directly to the wearer, without the involvement of a qualified eye care professional. Some foreign contact lens manufacturers have taken advantage of the ambiguity of the medical device regulation, selling costume contact lenses without the usual regulatory safeguards for medical devices – failing to provide adequate direction on cleaning and maintenance, and dispensing them without a prescription.

 “We’re very pleased that the Senate gave this issue the attention it deserves and passed the bill. We want to particularly thank Sen. DeWine and Senate Health, Education, Labor and Pensions Committee Chairman Michael Enzi for their leadership on this issue,” said Catherine G. Cohen, Academy vice president for governmental affairs. “We are very optimistic that the House will take prompt action as soon as the August recess ends and send the legislation on its way to the President for his signature.”