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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RK

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Event Date 05/15/1990
Event Type  Injury  
Event Description

I had the rk surgery done in 1990 and, while the procedure was done years ago, i have decreased vision, halo effect, diminished night vision, and "dehabilitated" daytime vision.

 
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Brand NameRK
Type of DeviceNA
MDR Report Key1037860
Report NumberMW5006635
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
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
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 05/01/2008 Patient Sequence Number: 1
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