FDA Issues Warning For Decorative Contact Lenses

Although decorative contact lenses are growing in popularity—being used for anything from enhancing a Halloween outfit, to matching an ensemble, to supporting a sports team—these are medical devices that require professional oversight, the U.S. Food and Drug Administration (FDA) warns.

Fashion or color contact lenses are not meant to correct vision issues and are generally used to change eye appearance. These lenses are neither cosmetic devices, nor are they over-the-counter (OTC) merchandise; decorative contact lenses are medical devices that are FDA regulated. This means that vendors advertising decorative contact lenses as cosmetics or that sell these devices without a prescription, are breaking the law. Contact lenses—all contact lenses, including decorative contact lenses—are not “one size fits all” and require an ophthalmologist or optometrist to measure each eye to ensure an appropriate fit and determine how the eyes responds to contact lens wear.

Poor contact lens fit can lead to a number of very serious reactions, including corneal scratches (scratches to the eyeball’s top layer), corneal infections (ulcers on the cornea), conjunctivitis (known as pink eye), decreased vision, and blindness. Also, vendors selling decorative lenses with no prescription might also not provide directions on how to wear, clean, and maintain the devices.

Not using appropriate solution and not keeping lenses clean and moist, can lead to eye infections, points out Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA. “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly. The problem isn’t with the decorative contacts themselves,” adds Lepri. “It’s the way people use them improperly—without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care.”

The FDA warns consumers to never buy contact lenses, which can be purchased without valid prescriptions for as low as $20 from street vendors, salons or beauty supply stores, boutiques, flea markets, novelty stores, Halloween stores, record or video stores, convenience stores, beach shops, and the Internet (unless the site requires a prescription). These are not authorized distributors of contact lenses, which are prescription devices by federal law.

Consumers desiring decorative contact lenses should undergo an eye exam from a licensed eye doctor (ophthalmologist or optometrist), regardless of vision needs and obtain a valid prescription that includes the brand name, lens measurements, and an expiration date. Doctors will not prescribe anime, or circle, lenses that are larger-than-normal and provide a wide-eyed, doll-like look. These lenses do not have FDA approval.

Only purchase lenses from sellers that require a prescription and follow directions for cleaning, disinfecting, and wearing the lenses; visit your eye doctor for follow-up eye exams. Redness, eye pain that does not dissipate, and vision decreases are signs of potential eye infections and should be immediately addressed by a qualified eye doctor.

The FDA discussed Laura Butler who paid $30 for her decorative lenses and $2,000 in medical bills, and who almost lost her eye. She purchased a pair of blue lenses at a souvenir shop, thinking they would be fun. No instructions or solution was provided.

“They felt fine, but they moved around on my eyes and I had to adjust them with my finger,” says Butler, who felt a sharp pain in her left eye. “It was such excruciating pain, I had to quickly pull over on the side of the road.” It took her 20 minutes to remove the lenses, which stuck to her eyes and cause her a “pain that was indescribable.” Butler was suffering from corneal abrasion. “The doctor said it was as if someone took sandpaper and sanded my cornea…. He said … I could lose my eyesight or could lose my eye.” After 10 days of doctor visits, seven weeks of follow-up care, eight weeks not being able to drive, five months of a drooping eyelid, ongoing decreased vision, and horrific pain, Butler escaped without an infection. “But the pain was agonizing. I
used to lay on the floor and roll back and forth in a fetal position for hours.” Says Butler, “Take the time to go to the doctor, pay the extra money, and save yourself the agony.”

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