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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Date 09/05/2014
Event Type  Injury  
Event Description

I had lasik surgery in (b)(6) 2014. The procedure was performed by dr (b)(6). I had been informed by dr (b)(6) and his staff, after my pre-operation evaluation, that i was a "terrific" candidate for the surgery and that my post-surgery vision would be 20/20. When i inquired into the potential side effects of the surgery, i was told that my vision would be blurry the day of the procedure and that my eyes would likely feel dry for several days or weeks afterwards. I was not informed of any other potential side-effects. In the six months since the procedure, i have experienced various unanticipated and life-altering side-effects. These side-effects include: my low-light vision is terrible: i cannot distinguish between objects and everything appears "grainy"; i am uncomfortable driving at night or dusk; i see large "starburst" around any source of light; this effect is particularly pronounced around headlights and street lights; i see halos around soft or covered light sources, such as lamps; my eyes are no extremely sensitive to bright light; on sunny days i have to wear sunglasses, and i cannot look at a bright computer monitor for more than a few minutes at a time; i have frequent low-grain headaches behind my eyes, particularly when i spend more than a few seconds looking at an object very close or very far; i also get eye exhaustion, a phenomenon i had never before experienced; in which my eyes simply need to rest; this typically occurs in the late afternoon or evening; and i have severly dry eyes, the one side-effect i had expected, though not six months after the procedure. In addition to the foregoing side-effects, i should also note that my vision is not 20/20. In (b)(6), i was measuring (according to my optometrist) -0. 5 in my right eye and -0. 75 in my left eye. I need to have this reevaluated, however, as i believe my vision has worsened since that item. In any event, i must now wear corrective lenses to address the under-correction. To sum up, it has been over six months since my lasik surgery. In that time my side-effects have not improved one bit, and my prescription seems to be worsening. My vison is fundamentally impaired, and i am reminded of that impairment nearly every minute of every days. As i type this, i have to continually blink or squint my eyes in order to focus on the words, which periodically swim. I have to use eye drops constantly, and avoid bright lights. On top of everything else, i still have to wear glasses defeating the whole point of getting lasik in the first place! the decision to have lasik ranks among one of the most regrettable of my life. I do not know whether these side-effects will abate over the coming months or years, but i have accepted the fact that, with each passing day, that is less likely to happen. I also do not know when my prescription will stabilize. What i do know is that, on top of the side-effects, i will always require corrective lenses.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key4628173
Report NumberMW5041610
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional

Date Received: 03/18/2015 Patient Sequence Number: 1