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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASIK LASER

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LASIK LASIK LASER Back to Search Results
Event Date 10/12/2005
Event Type  Injury  
Event Description

I am blind as a result of this procedure. I have no peripheral vision and there is an aura or some kink of colored light around every object that i am able to see. My eyes are extremely dry and swollen. My vision will never be restored. This is horrible. Diagnosis or reason for use: vision restoration. Event abated after use stopped or dose reduced? no.

 
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Brand NameLASIK
Type of DeviceLASIK LASER
MDR Report Key1132777
Report NumberMW5008056
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 08/21/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 08/21/2008 Patient Sequence Number: 1
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