Tag Archives: FDA

FDA Listens to LASIK Patients

On Friday, the Food and Drug Administration heard testimony from LASIK patients dissatisfied with the outcome of their surgeries. The ophthalmic devices panel heard testimony that approximately 1/4 of all patients that wished to have LASIK were poor candidates and 95% of LASIK patients were satisfied with the outcome of their surgery. Expert testimony before the panel concluded that the FDA should provide clearer warnings about the risks and possible complications of LASIK. Next year the FDA and the National Eye Institute will begin a landmark study to better identify which patients are more likely to encounter post surgical LASIK complications and how those complications affect quality of life. We compared the incidence of complications for patients having LASIK vs contact lens related complications in a prior blog entry.

I find that the FDA is not the only one that could improve their modus operandi here but that some of the marketing/advertising for refractive surgery is irresponsible. This over promise of results does not apply to just refractive surgery but also the bifocal lens implants promising to give your back your ability to see near and far without bifocals.

At Total Eye Care our role as optometrists is to provide the patient with an objective assessment, finding the best method of vision correction available for each patients situation. Today there are many refractive options available such as contact lenses, glasses, orthokeratology, PRK, LASIK and refractive lensectomies just to name a few. If a refractive option is selected it is our job to work with the patient to find the best surgeon and procedure for each patient to get the best, safest result. The Associated Press had good coverage regarding the ophthalmic devices hearing, if you would like to read it it’s available here.