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.) - "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 1511
Washington Avenue, Golden, Colo., 80401. Harper may be reached at 303-271-9644,
toll-free at 1-800-537-2845 or by e-mail at e-mail protected from spam bots. The
company website is http://www.techcolors.com.
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Source : http://www.prweb.com/releases/2003/9/prweb79188.htm