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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSURE UNSURE LASER EYE SURGERY

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UNSURE UNSURE LASER EYE SURGERY Back to Search Results
Event Date 01/01/2007
Event Type  Injury  
Event Description

A family member of mine has had the corrective laser eye surgery in both of her eyes. Since the surgery, her main eye doctor has removed her from that doctor's care and she is unable to see at night well enough to drive.

 
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Brand NameUNSURE
Type of DeviceLASER EYE SURGERY
Manufacturer (Section D)
UNSURE
MDR Report Key1515386
Report NumberMW5013139
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 10/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/20/2009 Patient Sequence Number: 1
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