LASIK and the FDA

May 01, 2008

After hearing a story about the FDA investigating reports of problems following LASIK eye surgery on NPR this morning, I followed the provided complaint link, and reported my experience to the FDA.  In the NPR story it was mentioned that it is believed as many as 5% of the nearly 1,000,000 LASIK patients per year have some difficulties following the surgery.  Unfortunately, the FDA has only received about 140 reports of issues in the past ten years.

If you had LASIK surgery and, like me, are experiencing vision that is less than what you expected, or worse, some debilitating side effects, please take 10 or 15 minutes and complete the FDA's adverse effect form.

The form isn't the most user-friendly, and is at times confusing.  You will need to enter a made up identifier on the initial page, and select the "adverse" category on the subsequent page.  I described my situation in detail on the next page, and skipped over all the drug/dosage type questions.  At the end information about the reporter (who may or may not be the affected individual) is collected.  I have no idea what will happen as a result of my submission, but I feel better for having reported my difficulties.

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Mark H. Nichols

I am a husband, cellist, code prole, nerd, technologist, and all around good guy living and working in fly-over country. You should follow me on Twitter.