16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
As it stands, the Contact Lens Rule is ineffective in regulating the patient's access to a medical device. Intended to protect the consumer, it instead promotes the business of unregulated online retailers and the commodification of a fitted medical device. While prescribers comply with providing a valid copy of the patient's prescription after examination of the eye and selection of appropriate lenses to ensure good ocular health and vision, there is no oversight of the contact lens retailers. The verification process is a joke. Prescribers must reply within a business day to a faxed or voice recorded request or the contact lenses will be dispensed. These requests are often times purposely sent in the middle of the night, recorded as a telephone message purposely delaying the name of the patient until the very end of the recording to make it difficult to pull up the patient's information to verify correct parameters, and most problematically a guise that retailers are complying with the regulations when the lenses have already been delivered to the patient (EVEN when prescribers have replied in a timely manner that the prescription is either INVALID or EXPIRED). The public can continue to get lenses online forever without having an eye exam, often only returning to their doctor after they have developed sight-threatening complications, e.g. infections,edema, scarring, redness and pain associated with contact lens intolerance. These complications are the result of contact lens abuse-- patients wearing whatever lens is cheapest for as long as they deem acceptable nowhere near what the FDA has approved. While it is the responsibility of the patient to comply by the contact lens replacement schedule and care recommendations made by their doctor, patients as consumers do not internalize the potential harm of over-wearing contact lenses in incorrect parameters when they can purchase contacts online as easily as they can purchase batteries or cosmetics.