Lasik Plaza

Real Time video of Lasik surgery using the Intralase to make the corneal flap and the VISX Excimer laser for the custom corneal ablation (reshaping). The procedure takes about 3-4 min per eye and is painless. Vision is restored immediately.

When it first approved laser devices for LASIK indications in 1995, CDRH screwed up in not applying its own less-than-1% standard for acceptable adverse events reported from clinical studies, former ophthalmic devices division director Morris Waxler told FDA Webview in a teleconference interview 9/3. Waxler said FDA was under enormous industry pressure when it approved the new indication and its standards for the procedure were cobbled together. Primarily, he said, CDRH totally lacked in-house LASIK expertise at the time and incorrectly judged the significance of adverse events, which the divisions own standards said should be less than 1% of all procedures. Actual experience was above 5% in permanent adverse events that the agency listed in the wrong column as so-called second-tier complications such as patient-reported persistent pain, blurred images and night-vision difficulties that were not counted as first-tier adverse events (retinal detachment, lost visual acuity, induction of astigmatism, etc.). I think we screwed up, Waxler said. Nobodys going to admit that. Basically, I think people made some of those judgments incorrectly. We were getting advice from very renowned ophthalmologists — more renowned than anyone we had in the agency. We dropped the ball.

Odigies epemvasis Lasik

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Arthur Benjamin, MD undergoing All-laser Intralase LASIK with Wavefront Allegretto.