Novelty Contact Lenses Are The Target Of Yet Another Statement From The Food And Drug Administration, This Time An Import Alert
Novelty contact lenses - from cat's eyes to sports team logos -- are the rage among teenagers these days, and the Food and Drug Administration (FDA) has issued another official statement - Import Alert #86-10, dated 4/1/03. FDA believes certain of these products coming into the country present substantial risks to ocular health, including corneal scarring and blindness, when dispensed without the involvement of a qualified eye care practitioner. In legal terms, they appear to be adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, according to the public document. The FDA issued a general warning last fall regarding problems associated with "unprescribed" novelty contact lenses.
Golden, Colo. (PRWEB) May 2, 2003 -- "As I've said before, I'm not sure why the FDA hasn't taken action earlier on this health issue, and I'm very happy to see all the appropriate sanctions now being put in place," Stan Harper, CEO of Adventures in Color Technology, says regarding the proliferation of novelty, or decorative, contact lenses that are dispensed without the involvement of an eye care practitioner for proper fitting and education regarding necessary hygiene practices. Harper is a former president of the Contact Lens Society of America.
According to the FDA's document: "This import alert was initiated in response to information indicating a risk of permanent eye damage, including corneal infections resulting in scarring and (potentially) blindness, resulting from product use and particularly wear beyond the recommended period, lens sharing between individuals, improper fit."
The products under question include: "Decorative contact lenses that are (1) intended to change the appearance of the eye in decorative fashion and (2) intended for distribution directly to the wearer, without the involvement of a qualified eye care professional. The import alert does not cover contact lenses that are intended for vision correction, prosthetic, or other medical use."
The FDA offers the following guidance: "Review all entries of contact lenses to determine their PMA/510(k) status. If a PMA/510(k) is not on file and the product is not listed on the Attachment, the product may be sampled and/or detained without physical examination as follows: (1) If the product is labeled solely to change the appearance of the eye in decorative fashion, districts may sample and/or detain the shipment using the charges cited in this alert. For further guidance, contact James F. Saviola, O.D., F.A.A.O., CDRH, Office of Device Evaluation (HFZ-460) (FAX 301-480-4201). (2) If the product is labeled for vision correction or prosthetic use, districts may detain the shipment using the appropriate charge as referenced in Import Alert# 89-08. Appropriate OASIS screening criteria has been set."
In addition to prosthetic/therapeutic applications for soft contact lenses, Harper's company creates custom contact lenses for theatrical use and custom novelty lenses for personal use. However, all of Adventures' lenses are individually prescribed, designed and fit under the direction of a licensed eye care practitioner.
Adventures In Color Technology, Ltd., serves eye care practitioners both in private practice and at teaching hospitals and universities throughout the world, developing colors and patterns for patients and continuing research for other retinal problems.
The company's headquarters is located at 1800 Jackson Street, Golden, Colo., 80401. Harper may be reached at 303-271-9644, toll-free at 1-800-537-2845 or by e-mail at info@techcolors.com. The company website is http://www.techcolors.com.
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