Every year, the approach of Halloween heightens fears at FDA that consumers will harm their eyes with unapproved decorative contact lenses. These are lenses that some people use to temporarily change their eye color or to make their eyes look weird—perhaps giving them an "eye-of-the-tiger" look.
"Although unauthorized use of decorative contact lenses is a concern year-round, Halloween is the time when people may be inclined to use them, perhaps as costume accessories," says James Saviola, the Ophthalmic and Ear, Nose and Throat Devices Network Leader in the Center for Devices and Radiological Health.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
The problem is not that people use decorative, non-corrective lenses. It's that many go about it the wrong way, which is dangerous.
Just like their corrective counterparts, decorative contacts—sometimes called plano, zero-powered or non-corrective lenses—are regulated by FDA.
"What troubles us is when they are bought and used without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care," says Saviola. "This can lead to significant risks of eye injuries, including blindness."
FDA is aware that consumers without valid prescriptions have bought decorative contact lenses from beauty salons, record stores, video stores, flea markets, convenience stores, beach shops and the Internet.
Recent legislation has made it illegal to market decorative contact lenses as over-the-counter products.
Unauthorized contact lenses of all types present risks to the eye that include corneal ulcers, corneal abrasion, vision impairment, and blindness.
If You Want Decorative Contacts
Get an eye exam from a licensed eye care professional, even if you feel your vision is perfect.
Get a valid prescription that includes the brand and lens dimensions.
Buy the lenses from an eye care professional or from a vendor who requires that you provide prescription information for the lenses.
Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye care professional for follow-up eye exams.