FDA To Study LASIK Patient Satisfaction

October 30th, 2009

What is the true complication rate for LASIK surgery? Who knows?  Last summer, in the New York Law Journal, I reported that depending on the source it varies from 1% to 20%.  There are two explanations for this large discrepancy.

First, most LASIK doctors do not report complications.  Hundreds of patients were injured by Alcon’s defective LADAR 6000 surgical laser, which had to be recalled.  Yet, only a minority of surgeons reported on injuries caused by the defective laser.  Ectasia is a rare complication of LASIK surgery.  Hyperopic ectasia, in farsighted patients, is rarer still. In the medical literature there is only one reported case of hyperopic ectasia.  In my law office, I have two. In neither case did the LASIK surgeon report the complication.  In one case, the ectasia followed 10 operations on one eye.  In the other case, the ectasia followed four operations on one eye.  Obviously, it would help the LASIK community, to say nothing of their patients, if doctors saw fit to report that repeated surgical procedures might be associated with LASIK complications, including hyperopic ectasia. The discrepancy turns on the definition of a complication.  Complications have been recognized to include sensitivity to light, difficulty in night driving, difficulty in reading, double vision, fluctuation in vision, glare, halos, starbursts, dryness, pain and foreign body.

Second, LASIK surgeons do not count dry eyes as a complication of LASIK surgery.  Rather, it is a mere side effect.  However, for patients with severe dry eye, it can be a visually disabling.

In April 2008, the FDA held hearings on LASIK complications.  To date, no report has resulted.  However, last week, the LA Times reported that, at last, the FDA has decided to examine patient satisfaction with LASIK surgery.  With the assistance of the Department of Defense and National Eye Institute, a multi-phase, multi-year, study is planned.

We will have to wait a while to learn whether the real complication for LASIK surgery is closer to 1% or 20%, and we will have to see how narrowly, or broadly, the FDA defines a “complication.”

Related posts:

  1. FDA Takes on LASIK Safety
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