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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIKNONE

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LASIK NONE   Back to Search Results
Event Date 04/11/2012
Event Type  Injury   Patient Outcome  Disability
Event Description

I had lasik surgery on (b)(6) 2012. Vision improved to 20/20. I went for my six week post surgery check-up on (b)(6) 2012 and notified the clinic that i had seen floaters for the first time on the friday before. On that wednesday morning, i experienced white flashes as well as many floaters. I was then refered to a retinal specialist that afternoon. The retinal dr found a tear or hole in the retina and performed surgery that same day to repair the damage. I am 5 days post surgery, still good vision. I was very myopic, -7 and was told that the retinas are thinner on people like me and are more prone to tears and that my episode was not related to the lasik surgery.

 
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Brand NameLASIK
Type of DeviceNONE
Device Event Key2574345
MDR Report Key2544688
Event Key2441421
Report NumberMW5025114
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/16/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2012
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? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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