Why Are Contact Lenses Medical Devices?

It seems I am constantly confronted with questions from some patients that wonder why contact lenses are considered medical devices. Many people think that contact lenses are simply commodities that should be sold over the counter and available everywhere without the requirement of a prescription. Here is an example of how patients can get into trouble if they misuse contact lenses and why they should be controlled by a prescription and only be available through doctors.

I had a patient that came in about six months ago for an eye exam. The patient had been complaining of discomfort when wearing his contact lenses. He was experiencing discharge from his eyes and redness. He also complained of blurred vision. Upon examining the patient and taking a history I learned that the patient had been given a pair of disposable one day single use contact lenses and had left them in his eyes overnight continuously for six months. The lenses were coated with mucous. His eyelids, on the underside, were significantly inflammed and there were multiple "bumps" on the underside of the eyelids (called giant papillary conjunctivitis) causing the localized mucous glands under the lids to produce even more mucous. His corneas were swollen contributing to his blurred vision and his discomfort. Basically his eyes were "a mess". I asked him why he had been using his contact lenses in this fashion and he said that he did not think there was anything wrong with his usage of the contact lenses and that it was no big deal. His friend who had the same "number for his eyes" had given him a pair and at first everything was fine. Unfortunately his problems caught up with him and yielded the result I have described above. I am not saying that this could not happen to a patient that received his lenses from a doctor. If a patient chooses to ignore the instructions and bend the rules of usage of contact lenses in spite of proper instructions from his health care practitioner, there is not much his doctor can do about it. The odds, however, are much greater that this kind of behavior will not occur if patients are instructed about what contact lenses can do and how to properly use and care for them. This patient was quite nearsighted and did not have any glasses. He had to get some emergency glasses and discontinue contacts for two months. He had to undergo treatment for his condition which involved eyedrops that were fairly expensive. After successful therapy he is now back wearing contact lenses with a much greater appreciation of what they are and how to properly care for them.

It is extrememly important for patients to understand that contact lenses are medical devices and they require proper care, handling and disinfection. They should be used according to their individual proper use instructions. Lenses that are to be worn overnight need to have a very high oxygen transmission. In additon, because they are left in overnight, they tend to become soiled quickly. It is important to not leave them in too long and to change them reqularly. There is always some increased risk when lenses are worn overnight as opposed to lenses that are used during waking hours and then cleaned and disinfected...or discarded daily as it the case with single use disposable contact lenses.

If a patient has any questions about proper contact lens care it is best for them to contact their eye doctor to make sure they are using their lenses in the proper manner.