Warning on Decorative Contact Lenses

by Food and Drug Administration (FDA)

Responsible and appropriate use is critical when it comes to contact lenses. That means getting an eye exam and a valid prescription, and buying contact lenses from an eye-care professional licensed to sell them. It's also essential to follow directions for cleaning and wearing the lenses and to have follow-up eye exams.

These precautions apply to all contact lenses, including non-corrective lenses intended solely to change the appearance of a normal eye in a decorative fashion, such as to turn brown eyes blue. These products present the same eye health risks as contact lenses intended for vision correction.

Fortunately, most decorative contact lenses are part of product lines that include a range of corrective powers, including non-corrective lenses, which have been authorized by the Food and Drug Administration for marketing. But the FDA has learned that some firms are not seeking FDA authorization before marketing decorative lenses.

The FDA recently issued a warning to consumers about the risk of permanent eye injury, and even blindness, associated with decorative contact lenses distributed without a prescription and without proper fitting by an eye-care professional. These products are being distributed through beauty salons, record stores, video stores, flea markets, convenience stores, beach shops, and other retail establishments.

Reports of Damage, Infections

The FDA has received reports of eye problems, such as damage to the cornea and eye infections, associated with decorative contact lenses. Most of the reports involve teen-agers. Victor Crosby, M.D., an ophthalmologist in Athens, Ga., reported a case of a 16-year-old female who bought contact lenses at a flea market. "She wore them for a couple of days and ended up in the emergency room with burning, redness, and sensitivity to light in both eyes," he says. "The main problem was a poor lens fit." Contact lenses that are too tight can damage the cornea. Crosby treated her with a topical steroid antibiotic for five to six days and she fully recovered.

Others haven't been as lucky. Thomas Steinemann, M.D., director of the Metro-Health Eye Clinic in Cleveland, treated one of the worst cases related to decorative contact lenses that has been reported to the FDA so far. In September 2001, a 14-year-old female needed treatment after wearing decorative contact lenses she bought for about $20 at a video store. "She wanted to turn brown eyes green to match an outfit," Steinemann says. "But the result was a lot of pain and suffering."

She experienced an aggressive infection caused by a Pseudomonas bacterium in one eye. "You can not only lose vision from this infection, but you can lose the eye," Steinemann says. The teen-ager had to be hospitalized and treated with antibiotic drops every 30 minutes for four days. "Though the infection was eradicated by aggressive topical therapy, the eye remained inflamed for a long time," he says. She was blind in the infected eye for two months. Soon after she began to regain some vision, scar tissue formed, causing further vision loss. In June 2002, Steinemann performed a corneal transplant, which involved removing her diseased cornea and replacing it with a donor cornea. Recovery from the corneal transplant takes about a year, and her vision is not fully restored.

Along with informing consumers about potential dangers with decorative contact lenses, the FDA is seizing decorative contact lenses on the market that violate federal law. The agency has also issued an import alert instructing the FDA and Customs officials to detain decorative contact lenses presented at U.S. ports of entry unless they have been cleared for marketing by the FDA. In a prepared statement issued in October 2002, FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., said, "FDA will aggressively use the full range of its statutory authorities to prevent the distribution of these potentially dangerous products to consumers."

Proper Fit, Prescription Needed

The FDA encourages consumers to discontinue use of decorative contact lenses obtained without proper fitting and a prescription, and to notify the FDA of any complaints or problems associated with these products. The American Academy of Ophthalmology also suggests that parents be aware of whether their children could be wearing decorative contacts.

It comes down to this question, Steinemann says: "Who is the advocate for the health of your eyes? It's not someone at a video store or a gas station."

Consumers and health professionals can report adverse events related to contact lenses to MedWatch, the FDA's voluntary reporting program.

Contact Lens Tips

• Wear contact lenses only if they are fitted and prescribed by an eye-care professional such as an ophthalmologist or an optometrist.
• Do not purchase contact lenses from gas stations, video stores, record shops, or any other vendor not authorized by law to dispense contact lenses.
• Never swim while wearing contact lenses. There is a risk of eye infection when contact lenses come into contact with bacteria in swimming pool water.
• Make sure contact lenses are properly cleaned and disinfected as instructed by your eye-care professional.
• Make sure you wash your hands before handling and cleaning your contact lenses.
• Never swap or share contact lenses with anyone.
• Never sleep while wearing contact lenses unless they are extended-wear lenses specifically designed for that purpose.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.