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Medical Devices

Fly Blind with Decorative Lenses

By Eileen Woo, RN, BSN

(Originally Published October 2003)

Case 1: A 20-year-old woman obtained tinted contact lenses without a prescription. After she wore them for 2 hours, she experienced excruciating pain and orbital edema. With treatment, her corneal injuries healed in a week.

Case 2: A 16-year-old girl who bought nonprescription contact lenses didn't get instructions on properly inserting, removing, or caring for them. After wearing the lenses for 24 hours, she had to go to an ED to have them removed. She had corneal abrasions in both eyes and secondary iritis. 

The Food and Drug Administration (FDA) has received several such reports of eye injuries associated with the use of nonprescription decorative contact lenses. People buy these lenses from convenience stores, video stores, flea markets, beauty shops, and other vendors not authorized by law to dispense contact lenses. One report involved a girl who'd borrowed them from a friend.

The use of decorative contact lenses without a professional prescription or fitting presents a significant risk for eye injury, vision impairment, and even blindness. For this reason, the FDA has issued a Public Health Web Notification warning consumers and eye-care professionals against their use. It also instructed FDA personnel and U.S. Customs officials to detain all decorative contact lenses presented at U.S. ports of entry. The FDA will seize decorative contact lenses currently on the market in violation of federal law.

If your patient wears lenses

If you encounter a patient who's been injured by using decorative nonprescription contact lenses, report the event to the FDA. Teach your lens-wearing patients these precautions:

  • Don't buy any contact lenses that aren't prescribed and fitted by an eye-care professional.
  • Don't wear any contact lenses that someone else has worn.
  • Seek medical care as soon as possible if wearing contact lenses causes pain or swelling or impairs your vision.

Eileen Woo is a nurse-consultant at the Center for Devices and Radiological Health of the Food and Drug Administration in Rockville, MD.

Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn't perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178; online at The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN. BS, MPH, coordinates Device Safety.


Page Last Updated: 08/05/2015
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