HERE IS A FULL DETAILED Report FROM THE FDA WEBSITE:
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."
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