| 22 September |
Former FDA LASIK regulator says FDA “Screwed Up” when it approved LASIK – ABC Good Morning America |
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.