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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Type  Injury  
Event Description

I had lasik surgery 4 yrs ago. I have been suffering from chronic dry eye since. When i first returned to the surgeon who performed the lasik surgery, he informed me that my surgical incision had healed beautifully, and that he did not have an answer as to the constant red eyes. After two yrs, and 200 bottles of visine later, i finally went to another dr who informed me that i had been suffering as a result of the lasik surgery. We gave our college aged son the lasik surgery as a birthday gift the same year!.

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Type of DeviceLASIK
MDR Report Key1183965
Report NumberMW5008500
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Date Received: 10/01/2008 Patient Sequence Number: 1