16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
The Contact Lens Rule (the Rule) is required by statute, the Fairness to Contact Lens Consumers Act (FCLCA). The Rule has concerned me for the entirety of its existence, which now is more than a decade. As a faculty member in the ophthalmology department of the Jules Stein Eye Institute of the David Geffen School of Medicine at UCLA, I personally provided both contact lenses and eye care for 33 years. Currently, I teach, conduct research, and provide care for a limited number of patients at the Southern California College of Optometry at Marshall B. Ketchum University in Fullerton, CA. Thus, I feel it is important to indicate at the onset of my comments that I have no economic interest in the sale of contact lenses. However, I have a longstanding professional and strong personal commitment to patient care. I believe that distributing contact lenses without the supervision of an eye care professional results in patient harm. Individuals can suffer from vision and other health complications stemming from the improper use of optical prescriptions. During my four-decade career in optometry, I observed many instances of improper prescription verification, including substitution of prescribed lens products and incorrect filling of prescriptions, and lens dispensing and subsequent harm. Most of the health risks of contact lens wearers are mild and easily manageable -- if those wearers subsequently see a licensed eye care professional. However, some complications can cause vision loss if they are left untreated. I have co-authored a case study that highlights the dangers of improper use of contact lenses. The study is attached for your consideration (Wong, et al. 2003). In this case study, the patient went five years without seeing an eye doctor yet was able to obtain her replacement contact lenses through a non-professional source without prescription. The patient suffered adverse effects. Unfortunately, this is not an isolated incident. Moreover, I am also an author of a large study published from research conducted at UCLA. My colleagues and I reported on 572 contact lens-wearing patients (Forister, et al. 2009); 50 percent of whom had early contact lens complications worthy of management by an eye care professional; If these patients delayed care, they would have developed worse ocular problems. 98.5 percent of that population had no subjective symptoms of any problems. This study is attached. The more often eye care professionals see patients, the more they can try to improve their care of contact lenses. Contact lens care education has been shown to minimize the risks of complications (Keay & Stapleton, 2008). Furthermore, Stapleton, et al. (2008) documents that 5 percent of the risk of corneal infection is associated with Internet purchase of contact lenses; the study is attached. Indeed, the Centers for Disease Control and Prevention (CDC) has documented the tremendous economic cost to consumers, taxpayers and the health care system to treat complications arising from contact lens usage: "…The total cost of the estimated 988,000 visits to doctor's offices, outpatient clinics, and emergency departments for keratitis and contact lens related diagnostic codes was $174.9 million, including $58.0 million in costs for Medicare patients and $11.9 million in costs for Medicaid patients..." (Morbidity and Mortality Weekly Report, Vol. 63, No. 45, November 14, 2014). The passive prescription verification system encourages abuse by the non-professional distributers of contact lenses and ultimately hurts the consumers who do not understand the possible risks. Thus, I strongly urge you to institute an active verification model. In the U.S., we utilize an active verification system for prescription drugs for the safety of patients. Contact lenses are medical devices. Therefore, it is reasonable to replace passive verification with active verification for contact lenses. Thank you in advance for considering my comments.