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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASIK

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LASIK LASIK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Visual Impairment (2138); Loss of Vision (2139); Visual Disturbances (2140); Vitreous Detachment (2445)
Event Date 09/18/2011
Event Type  Injury  
Event Description
I had lasik in (b)(6) 2011, i was having flashing lights in my right field of vision and went to the er and then to eye specialist and was diagnosed with posterior vitreous detachment. I am now having other problems in my right eye reduced vision, swollen optic nerve, and irregular color vision between two eyes, and possible epiretina membrane. I am waiting for more test results to come back. I do believe i maybe having these issues due to having lasik.
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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key2334939
MDR Text Key2363038
Report NumberMW5023038
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 11/07/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2011
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No

Patient Treatment Data
Date Received: 11/07/2011 Patient Sequence Number: 1