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.
Former FDA Regulator Says LASIK Side Effects Weren’t Taken Seriously Enough. Excerpt: “But while the FDA was aware of negative side effects that would occur in some, Morris Waxler, the former head of the FDA branch responsible for reviewing the data on LASIK, told ABC News in his first television interview that, in hindsight, those side effects were not taken seriously enough… “I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he said. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.”
Orthokeratology is known by numerous names and the technique has change greatly over the years. Various forms of Ortho-K have been practiced for about 40 years. The technique first involved using progressively flatter lenses to flatten the cornea causing the patient to become less nearsighted. This early method required months to show results and the patients had to wear their lenses during part of each day or wore them on alternating days.
Yesterday morning I had Lasik in my right eye and PKR in my left eye. A day and a half later I my Lasik eye is still blurry. The doctor said it’s somewhat normal because I had a strong astimatism and very poor sight to begin with. Should I be worried? How much time should I give it before I worry?
