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Halloween Contact Lenses Don't Need To Be Scary If You Take Precautions Suggested By Licensed Eye Care Practitioners And Heed The Alerts And Warnings Of The Food And Drug Administration (FDA) Over The Past Year

Halloween contacts (novelty contacts) - from cat's eyes to sports team logos -- are the rage among teenagers these days, and during the past year the FDA has issued Import Alert #86-10, dated 4/1/03, and a general warning last fall regarding problems associated with "unprescribed" novelty contact lenses. Despite all the concern, Halloween contact lenses don't need to be scary, according to Stan Harper, contact lens expert and former president of the Contact Lens Society of America, if people receive proper fitting and practice good hygiene.

Golden, Colo. (PRWEB) September 8, 2003 -- "I'm not sure why the FDA hadn't taken action earlier on this health issue," says Stan Harper, CEO of Adventures in Color Technology, Ltd., in an interview last year with the Fredericksburg, VA, Free Lance-Star, "The real source of the trouble is sharing contacts. First Mary wants to try them on, and then the next person tries them on. They don't get disinfected."

According to the FDA's official warning: "Decorative contact lenses present significant risks of blindness and other eye injury if they are distributed without a prescription or without proper fitting by a qualified eye care professional. FDA has received reports of corneal ulcer associated with wear of decorative contact lenses in excess of the recommended period. Corneal ulcer can progress rapidly, leading to internal ocular infection if left untreated. Uncontrolled infection can lead to corneal scarring and vision impairment. In extreme cases, this condition can result in blindness and eye loss.

"Other risks associated with use of decorative contact lenses include conjunctivitis (an infection of the eye); corneal edema (swelling); allergic reaction; corneal abrasion from poor lens fit; and reduction in visual acuity, contrast sensitivity, and other visual functions, resulting in interference with driving and other activities."

Last April, the FDA issued an Import Alert regarding the novelty contact lens issue. 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."

According to the Fredericksburg paper, the biggest problem to overcome is that teens think the mass- produced, novelty contacts are cool. "I guess that falls in the same area as piercing your tongue or your nose," Harper said in the newspaper interview, "I think they want to appear different than the one next door. I think they want to be a little bit outstanding."

Adventures In Color Technology 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. Hopefully, to soon help patients with macular degeneration, a debilitating loss of vision as the macula in the back of the eye becomes less and less responsive to light entering the eye through the pupil. This condition is the leading cause of blindness in our older population.

In addition to prosthetic/therapeutic applications, 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.

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. The company website is http://www.techcolors.com.

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