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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 Date 05/17/2008
Event Type  Injury  
Event Description

Approx 6 weeks after lasik surgery, i noticed that points of light at night are doubled -e. G. , instead of one red traffic light, i see two-. Surprisingly, i don't notice much of the haloing and starbursting that are usually described as lasik night vision problems. I have also noticed that i experience double vision in my right eye during the day time. This is most noticeable when trying to read a ruler or tape measure. All the graduation lines are doubled and i have to close my right eye to determine the correct measurement. I have also noticed a dramatic increase in the number and density of the vitreous opacitities -floaters- in my vision. This increase also occurred at approx 6 weeks post surgery.

 
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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1230095
Report NumberMW5008966
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 11/12/2008 Patient Sequence Number: 1
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