Tags: Duke Medical Center  Duke Health System  LASIK  Intralase  Duke LASIK  risks  complications  
Channel: News & Politics
Uploaded: December 31, 1969 at 6:59 pm
Author: thetruth8699
Length: 04:13
Rating: 5.0
Views: 330
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.