Articles about Eye Health and Disease 2002
 

FDA to Seize Illegally Obtained Contact Lenses in Response to Academy Work

November 2002

Representatives from the American Academy of Ophthalmology met with representatives of the Food and Drug Administration (FDA) on November 1, 2002, to provide 15 case studies it collected showing adverse affects from cosmetic contact lenses (zero power colored lenses) distributed without a prescription. Two weeks ago the FDA announced that it would aggressively move to prevent the distribution of these potentially dangerous products directly to consumers, and now plans to file a complaint and proceed to seize products that are being marketed and distributed without a prescription and without proper fitting by an eye care professional. Retail shops contacted by the FDA have voluntarily withdrawn the product.

The timing was right in that interest in the lenses could be expected to increase in the Halloween season, and most of the patients presenting with problems are teenagers. The Academy contacted the FDA in September with concerns about the significant risks of blindness and other eye injuries from these illegal lenses. The FDA has issued an import alert instructing FDA and Customs officials automatically to detain all decorative lenses presented at U.S. ports of entry, and will also issue a public health notice that these lenses must not be dispensed without a prescription. FDA expects some foreign manufacturers to challenge its prescription and safety requirements.

Academy members are asked to be vigilant in educating the public on the risk of using these non-prescription lenses, and to contact Pat Eddington at with any adverse consequences they have seen in patients. In addition, Academy members are encouraged to submit studies/cases to peer-reviewed journals for publication.

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