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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Event Date 05/05/2000
Event Type  Injury  
Event Description

I had lasik surgery in 2000. My vision before surgery was considered legally blind. I wore contacts prior to the surgery but my dr said that because of eye infections, i would go blind if i continued wearing contacts. I decided to get the lasik procedure. I was the 95th person my dr had performed the surgery in his facility. I was given valium before the surgery which made me jittery and made my palms sweat - the opposite reaction they were expecting. The surgery went well and the first couple of post-operative visits were fine, just a little blurry. Within a few days, i had a blurry spot where i could not see in my right eye. If i turned my head sometimes i could see fine from that eye. Anyway, after weeks of appointment, steroids and consultations with other physicians, it was determined that i had oil -sweat- under my flap. It eventually cleared up. I have had major halos at night. Oncoming traffic from a distance appears as large firework burts. When traffic approaches, my eye contracts and my vision is better. When i walk in the dark outside, small lights appear huge, such as doorbell lights seem big when i'm walking down the street. I have been told i have huge pupils. My present ophthalmologist says i have the largest pupils she has ever seen. My night vision is the pits. I see large fireworks. In addition, i was now told that when the lasik physician performed the surgery, he did not make my left eye my dominate distance eye. I am left-handed. I now have cataracts which were diagnosed. I was told that the operative site for the lasik is smaller than the area my eye dilates and that the blurriness comes when my eyes dilate, at night and i'm seeing my old vision on the outside of my pupil. Before my surgery, i wore a -9 in contact lenses. I do see lots better than i did without glasses but the night vision problems are permanent, and i usually avoid most night driving. I have some new driving glasses which helps a little bit, mostly because they bring my left eye event with my right eye or make my left eye more dominant.

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MDR Report Key1037826
Report NumberMW5006606
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 05/01/2008 Patient Sequence Number: 1