16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00035

Submission Number:
00035
Commenter:
Lee Raykovicz
State:
North Carolina
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
This amounts to common sense. As FDA regulated medical devices, contact lenses and their prescriptions need to be updated yearly as part of a regular contact lens and eye health evaluation. Based on findings, the doctor will then make recommendations as to health, wearing schedule, replacement schedule, and other issues related to the health and well being of the patients. Third party "passive verification" of prescriptions, unauthorized filling of incorrect, inaccurate, invalid, or expired prescriptions, and perpetuating the notion to the public that contact lenses are a "one size fits all" is negligent and puts the public in harms way. Serious complications can be had with improper fit, education, and follow up of contact lens patients, including but not limited to: abnormal corneal blood vessels and inflammation, chronic allergic conjunctivitis, corneal inflammation and infection, loss of best corrected vision, and in rare circumstances the need for corneal transplant, or loss of the eye. It is well known and documented that third party sellers often will "verify" a contact lens prescription via fax at odd hours (i.e. middle of the night/weekends), and often fill online orders with or without an updated, signed prescription from a licensed provider. It's really no different than prescribing medications without a valid prescription and should no longer be tolerated. It's a matter of public health.