Google/AP
WASHINGTON — The Food and Drug Administration announced plans Thursday to study the scope of problems connected with laser eye-correcting surgery, which include blurred vision and dry eyes.
The FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience negative side effects following surgery.
The first phase of the project is already under way, with plans for an online questionnaire to help patients gauge their quality of life following surgery, according to an FDA statement.
The project will also include a clinical trial tracking patients who undergo the procedure, which is expected to conclude by 2012.
2 comments:
This is great news...a question though, it says in the article..
'Also on Thursday, the FDA announced warning letters sent to 17 Lasik surgery centers for inadequate adverse event reporting procedures. Regulators periodically send letters to facilities that don't follow federal guidelines for reporting patient complaints.'
Does this mean that my Lasik surgeon is/was obliged to report my case of dry eyes to the FDA? If this is the case, how do I know if he did or not?
B.
Those warning letters went to ambulatory surgical centers (I'm not sure how common those are anymore for LASIK). And I'm not familiar with the special reporting regulations regarding such facilities.
But as to whether your doctor is required to report your dry eye to the FDA: It's a good question and reminds me how long it's been since I've looked into this. I know that the manufacturer is required to report any significant complication of which it becomes aware, period, within a certain number of days of learning it; equally certain is that for years all manufacturers ignored this regulation almost totally, and many still do. I remember when I could count the number of LASIK MDRs on my fingers and toes - while at the same time medical literature had far more. - Not all that long ago, Alcon was investigated by the FDA for failing to report complications from the Ladarvision lasers. After that investigation they reported things left and right including reporting complications that appeared in medical journals!
But back to the question of dry eye. Neither doctors nor manufacturers consider this a "complication", as opposed to an adverse effect, so in general it is not reported as such. In my opinion, cases of severe dry eye should be reported, and the current FDA action suggests that this information is important to them. You can report it yourself and I would encourage you to! Here's a link:
http://www.lasermyeye.org/patients/filinganmdr.html
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