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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 Name
Type of Device
MDR Report Key3599054
MDR Text Key19973116
Report NumberMW5033995
Device Sequence Number1
Product Code LZS
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/27/2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age24 YR
Patient Weight49