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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 05/10/1999
Event Type  Injury  
Event Description

I received lasik eye surgery. Within one to two years, i noticed halos while driving at night and was given night driving glasses. Every year at my annual eye exam, i would complain that my eye sight was deteriorating. In 2007, i was diagnosed with "kerakatonis" in my right eye and chronic dry eye both caused by the lasik eye surgery. I now have to wear expensive synergy contacts and go into my optometrist's office once a month due to inflammation, tear duct plugs falling out, and other problems associated with both conditions. I have to go days without wearing my right contact while my eye heals; however, i can't drive and see well. Diagnosis or reason for use: corrective eye surgery.

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Type of DeviceLASIK
MDR Report Key1304447
Report NumberMW5009860
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 02/03/2009 Patient Sequence Number: 1