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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Event Type  Injury  
Event Description

I read that the fda is investigating the side effects of lasik. I had a congenital crossed eye that was corrected by surgery. Immediately after the lasik, i noticed that my eye began to cross again. My specialist told me this is not uncommon after lasik as the procedure affects the neurological pathways between the eye and the brain. I was never warned that a recurrence of the crossed eye was a possible side effect of lasik. I had to undergo another surgery to correct the crossed eye. I feel that other pts with a similar history of this condition should be warned of this potential side effect.

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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1513495
Report NumberMW5013059
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2009
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: 10/16/2009 Patient Sequence Number: 1