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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 01/05/2005
Event Type  Injury  
Event Description

I have debilitating complications from lasik surgery. Severe and constant eye pain, severe dry eye, my eyes now have severe reactions to wind, air, heat or air conditioning, and i can not wear makeup as the dust/fumes create pain and tearing. I am unable to spend prolonged time at a computer screen or read without suffering eye pain. I am unable to work outside the home because of these issues. My life has been changed for the worse due to the surgery. I suffer from fibromyalgia-and did at the time of the surgery-and most like undiagnosed dry eye. The potential complications of the surgery were not made clear, and there was surely not sufficient screening considering my pre-existing conditions. The whole process in the doctor office was unlike a manufacturing production line atmosphere. From the interview to the actual process, it was unlike any other surgery. Very production/through put oriented at all levels.

 
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Brand NameNA
Type of DeviceLASIK
MDR Report Key1584204
Report NumberMW5014409
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2010
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: 01/16/2010 Patient Sequence Number: 1
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