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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description

After having lasik eye laser surgery, i feel that my vision at night has become terrible. I have also noticed i feel the need for more light to see accurately that the average person. I feel that the lights indoors are never bright enough and i need more light generally to see well.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key3599054
MDR Text Key19973116
Report NumberMW5033995
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/26/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL

Patient TREATMENT DATA
Date Received: 01/27/2014 Patient Sequence Number: 1
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