Question of the Week

November 4, 2002


"Dr. Thomas E. Steinemann, a Cleveland ophthalmologist, has seen his fair share of patients with tragic eye disorders. But few have been sadder, he said, than the teenager whose vision was permanently damaged last year by a pair of contact lenses she wore solely to change the color of her eyes.... [She] wore her green lenses just once, to a party one night in September 2001. When she saw Dr. Steinemann the next morning, her eyes were red and oozing pus from a bacterial infection. Dr. Steinemann put her in the hospital for 'intensive antibiotic therapy.' She spent four days in intensive care. The girl suffered permanent vision damage, Dr. Steinemann said, when scar tissue developed on her cornea."

Are non-prescription contact lenses a medical device or a fashion accessory?

Making a Fashion Statement Not Worth Losing Your Sight. Schaumburg, IL - On the surface, it seems like a very cool, hip way to impress your friends. Wearing crazy, colorful contact lenses in myriad patterns and designs is quite a way to make a fashion statement. Movie stars and rock stars wear them..."

Are non-prescription contact lenses a medical device or a fashion accessory?

"Last week, the FDA warned consumers about costume or 'decorative' contact lenses sold illegally, without prescriptions, often from retail outlets such as beauty salons or beachwear stores. The FDA stated, 'These products present risks of blindness and other eye injury if distributed without the involvement of a qualified eye care professional.' Eye M.D.s have reported treating patients, mostly teenagers, for problems associated with wearing costume contact lenses obtained without prescriptions from vendors who are not licensed to dispense contact lenses."

Are non-prescription contact lenses a medical device or a fashion accessory? These lenses are readily available, and the argument rages on between companies that manufacture them and the doctors who see the consequences when the contact lenses are not fit properly by an eye care professional. Companies claim that these lenses do not correct vision, and thus should be considered cosmetics. Doctors argue that these medical devices (whether prescription or not) have the potential to change and/or harm the vision of the person using the product. According to the FDA, even cosmetics need to prove that they will not harm the user.

The FDA, ophthalmologists, teens, pre-teens, parents, and those who make and sell the products are all involved. Everyone sees a different side of the story. Would teens and parents view the issue differently if they had more information? Are ophthalmologists over-reacting because they only see the cases where there have been problems? Are the companies who market the product giving the consumers enough information to make an educated decision before choosing whether or not to use the product? Should ophthalmologists be using the press to inform parents of the risks so that they can talk with their teens about safe use and fitting of contact lenses?

Questions of the Week:
Who should decide whether non-prescription contact lenses are a medical device or a fashion accessory? Would either classification make a difference to the teens who are wearing them? What could be done to make use of the products safer for those who are interested in trying them?

Please email me with any ideas or suggestions.
Note: Due to increasing amounts of SPAM sent to this account, please include "QOW" in the subject line when sending me email.

I look forward to reading what you have to say.

Health Community Coordinator
Access Excellence @ the National Health Museum

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