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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK ALL WAVEFRONT

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LASIK ALL WAVEFRONT Back to Search Results
Event Date 04/15/2013
Event Type  Injury  
Event Description

I had lasik refractive surgery and 2. 5 months later started experiencing bright flashing lights in my left eye. I went back to the doctor whom performed my lasik procedure and was told that my symptoms were not related to my laser surgery. He referred me to a retinal specialist whom i saw the same day. The retinal specialist examined my eye and found two tears in my retina. He then performed surgery that day. I was told that the retinal tears were common with people like me who were nearsighted. I'm only (b)(6) and my nearsightedness prior to lasik was not on the severe side.

 
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Brand NameLASIK ALL WAVEFRONT
Type of DeviceLASIK
MDR Report Key3233918
Report NumberMW5030924
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/14/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2013
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

Patient TREATMENT DATA
Date Received: 07/14/2013 Patient Sequence Number: 1
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