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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 09/15/2000
Event Type  Injury  
Event Description

I had lasik surgery on my left eye only despite my ophthalmologist's urging that i do both eyes. I had read of the possibility that i would see an aura around lights at night after surgery and did not want to take the chance that would happen on both eyes. I had it done on my eye with the worse vision, 14 diopters. After it was done my vision in that eye was about 1 diopter. It progressed to 3. 5 diopters fairly rapidly and is now at 6. 5 diopters. My complaint is that i read in an ophthalmology text book about six months after the surgery that surgery was not recommended for people with vision of 8 diopters or worse and also that it was not recommended for people of my age. I had the surgery done at a med ctr and the physician should have known this info, but he did not inform me even though i did ask the questions.

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Type of DeviceLASIK
MDR Report Key1037798
Report NumberMW5006579
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
Was Device Available For Evaluation? No
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