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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK SURGERY

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PRK SURGERY Back to Search Results
Event Date 12/17/2011
Event Type  Injury  
Event Description

I had prk surgery on both eyes in 2001 while on active duty, (b)(6). Had to undergo it several months later due to scarring. Noticed i had to wear sunglasses at all times after that and my night/low light vision was greatly diminished. Started getting migraine headaches. Symptoms progressed till in (b)(6) 2011 i woke up in the emergency room of an apparent seizure. This occurred again in (b)(6) 2012 and i was then diagnosed with seizure syndrome. My left eye lid sticks to my eyeball at night which triggers the seizure and causes extreme pain in that eye and a migraine headache. My short term memory is worsening. I am now on blood pressure meds. I have lost my job due to this. Even with the seizure meds i sometimes have painful nightly episodes of these side effects.

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Type of DevicePRK SURGERY
MDR Report Key5535571
Report NumberMW5061340
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Report Date 03/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
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: 03/25/2016 Patient Sequence Number: 1