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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK/LASIK

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Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); Pain (1994); Phototoxicity (2165); Disability (2371)
Event Date 09/04/2012
Event Type  Injury  
Event Description
I had prk refractive surgery done in (b)(6) 2012. I have been diagnosed with photophobia. Ever since i have had to use sunglasses pretty much all the time during day time, in sun light, artificial light, during night time, and while driving. I went to my ophthalmologist, and he said that he has never seen a situation like mine. I experience eye pain like a sharp knife stabbed me in my eyes when exposed to light for short periods of time. After exposure for around two hours i start to experience a migraine type headache that obligates me to shut down and take a 2 hour sleep along with at least 800 milligrams of ibuprofen to get rid of the pain. My military career is being seriously affected. My time and activities with my wife and children are being affected. I am forced to wear dark sunglasses all the time, indoors and outdoors. I have read of multiple similar cases like mine after lasik/prk and other eye surgeries. I sometimes take off my sunglasses just to confirm that i am not imagining things, but after a few seconds there is the pain again. I think that the fda really needs to pay attention to this matter and study or suspend this procedure until it has been further studied.
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Type of DevicePRK/LASIK
MDR Report Key4024389
MDR Text Key20324618
Report NumberMW5037739
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 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator

Patient Treatment Data
Date Received: 08/13/2014 Patient Sequence Number: 1