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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK

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PRK Back to Search Results
Event Date 04/03/2006
Event Type  Injury  
Event Description

I underwent prk at (b)(6) while on active duty in the (b)(6). While the procedure did offer temporary correction to my astigmatism, the resulting symptoms of chronic dry eyes, pain and headaches persists.

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Brand NamePRK
Type of DevicePRK
MDR Report Key6116515
Report NumberMW5066200
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Report Date 11/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 11/17/2016 Patient Sequence Number: 1