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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM VU WAVEFRONT LASIK

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CUSTOM VU WAVEFRONT LASIK Back to Search Results
Event Date 07/09/2007
Event Type  No Answer Provided  
Event Description

I had lasik surgery on (b)(6) 2007. The surgery was performed within 4 hrs of my initial visit. I have not had clear vision since the day of surgery. My problems include dry eyes, halos, starbursts, no contrast ability, lack of peripheal vision, extreme sensitivity to light, and now bilateral cataracts. I was told at every visit that these complications would resolve over time. Of anything, my symptoms have become worse. I faced an unk amount of surgeries to remove the cataracts and i am concerned about the instability of my corneas, which have been damaged and will at some point require corneal transplantation. At the time of my surgery, i was earning in excess of (b)(6) per yr. Due to my declining visual ability and debilitating depression, i am on (b)(6), wherein i receive a monthly stipend of (b)(6). I have attempted suicide more than 5 times since my lasik.

 
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Brand NameCUSTOM VU WAVEFRONT
Type of DeviceLASIK
MDR Report Key2019933
Report NumberMW5019782
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 03/10/2011 Patient Sequence Number: 1
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