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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 12/01/2005
Event Type  Other  
Event Description

I underwent lasik surgery in late 2005. I have dry eye complications from that surgery. I heard through the news about the fda hearing today and was dismayed at the fact that only 140 complaints were made. I need to know what i should do to let the fda know about my complications. Please provide me with instructions. I am desperate to have the lasik industry changed to protect future pts. (as a side note, i was a healthcare admin for over 10 yrs, and before that a scientific researcher- so i was a little appalled hearing that less than 1% of lasik pts have complications- there is much research, websites, etc. That prove otherwise). Your advice and direction will be greatly appreciated.

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Type of DeviceLASIK
MDR Report Key1069870
Report NumberMW5007514
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/25/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No