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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Retinal Detachment (2047); Blurred Vision (2137); Visual Impairment (2138)
Event Date 02/20/2014
Event Type  Other  
Event Description
Caller reports he had lasik surgery performed in his right eye in (b)(6) of 2014. Two days after the procedure he reports that his vision started to become distorted and darker. Caller states he went to the doctor and found that his retina was detached and an emergency surgery was performed on (b)(6) 2014. Caller reports that he is still experiencing vision issues.
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key3983418
MDR Text Key20756901
Report NumberMW5037609
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/01/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No