16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00551

Submission Number:
Darryl Voight
New Jersey
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
I've been in private practice for 20 years. Overall, I am in agreement with the requirement to release a patient's CL prescription at the time of the exam visit, as long as they are not experiencing any significant CL related medical issues, and there is no open balance on their account. However, since the implementation of the Fairness in CL Act, we have seen an abuse of the requirements by many CL Suppliers. First, the requirement that we respond to a fax request within 8 "business" hours OR the CL prescription is considered "valid" is not a realistic time frame. I would suggest something on the order of 2-3 business days. Some offices are closed certain days and/or open at different hours (e.g. we work 1-8pm on Thursdays) and the 8 hour rule overly burdens the doctor's office to comply. Also, I have seen many, many examples of patients who come back for an eye exam over 2 years later, but were able to purchase CLs after their initial supply ran out and/or 2 years had passed since their last eye exam. So basically, patients seem to have no issues obtaining CLs from online suppliers even after their CL prescription is over 2 years old. Lastly, I can't express enough the importance and need for ongoing CL health evaluations (at least every 1-2 years), to insure patients are complying with recommended safe and healthy CL wearing practices. Some of the (many) examples of what I've encountered are: Patients report only changing their CL solution in the case "once a week when it looks dirty", or "every two weeks when I change my CLs". And many, many patients sleep in the same pair of CLs for days, weeks and sometimes months at a time, even when they are experiencing recurring symptoms of discomfort and/or redness and/or blurred vision in one or both eyes. And now with the introduction of "Daily" CLs, I see patients (young and old, experienced and less experienced) sleeping in a single use, daily disposable contacts. It's not unusual to see a patient with a red, painful eye after sleeping in a daily CL just 1 night. Most daily CLs still do not provide adequate oxygen permeability for overnight wear. And even ones that do can still cause a medical problem is it fits too tight or adheres onto the eye overnight. Furthermore, I cannot stress enough the concept that CLs are indeed a "medical device" that requires ongoing evaluation by a licensed, professional eye care provider (Optometrist or Ophthalmologist). Anything less is simply asking for many more patients to misuse/abuse their CLs and incur more medical problems. Based on work with the American Optometric Association, Vistakon (makers of Acuvue) prepared a CL patient educational agreement that states in part "It is my understanding that improper use and inadequate care of contact lenses prescribed for me can possibly lead to eye irritation, infections, corneal injury and permanent vision loss". We added that language to our CL fitting agreement and I cannot stress enough that those words should be the overarching guidance related to any legislation governing the use, purchase and/or sale of CLs in the USA.