16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00667

Submission Number:
00667
Commenter:
Lange
State:
Texas
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
It is my professional opinion that strict standards and controls must remain intact for controlled medical devices, such as contact lenses. When utilized responsibly, and in a manner consistent with which they have been prescribed, contact lenses offer correction of refractive error in a convenient modality with certain advantages over traditional spectacle wear; however, the use of these medical devices is not without risk. Incorrect or errant contact lens prescriptions (which we receive requests for on a semi-daily basis, even with the current verification system in place) can cause changes in eye alignment, double vision, strain on the visual system and associated musculature, poor visual acuity (outside of legal limits for operating motor vehicles), permanent increases in refractive error, and more. Furthermore, to account for the multitude of corneal shapes, sizes, and curvatures, as well as ocular and conjunctival allergy responses and sensitivities, contact lenses are manufactured in numerous permutations of base curves, diameters, stabilization designs, and materials in order to ensure that patient ocular health is not compromised as a result of their regular wear. Despite the opinion that non-medical-professionals may hold, these properties of contact lenses are significant, and all contact lenses are not alike. I have seen in practice, the permanent negative effects suffered by patients who have illegally obtained and utilized contact lenses outside of the discretion of their physician including corneal edema, giant papillary conjunctivitis, corneal hypoxia and subsequent neovascularization, ocular infections, permanent stromal scarring with significantly reduced visual acuity, and potentially penetrating lesions that may compromise the globe as a whole; all of which can be significantly minimized, or virtually eliminated under proper physician care. To expose the public to such appreciable risks under the guise of mere consumerism, would be nothing short of negligent. Contact lenses are purposefully and rightfully designated as controlled medical devices, and absolutely should remain as such. Thank you for your time and consideration.