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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
Combination Product (Y/N)
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

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