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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER

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LASER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Pain (1994)
Event Date 11/18/2008
Event Type  Injury  
Event Description
I got prk surgery when i was in the air force and i regret it. It's been 5 yrs and my eyes constantly hurt and are super dry. When i wake up and my eyes open, it feels like i opened them in chlorine water. I think they are getting worse some days i cannot touch the lid of my left eye. What is worse is still need glasses so all that pain and difficult post-op pain was for nothing. Prior to my surgery, i spoke to a fellow airman who had warned me but i thought it must have been a unique situation and didn't listen to her, so i know i'm not the only one. Now i'm constantly using eyedrops and taking eye vitamins to see if that helps and it does but only so much. The drops help with the dryness, but not the pain. When a group of us were getting the surgery that day, i remember being in a room and being handed a bunch of papers, liability forms i'm sure, and not being explained anything; that day i remember asking if we had to option to getting lasik and i was told no very rudely. I was not at any point explained of the possibility life long effects of prk.
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Brand NameLASER
Type of DeviceLASER
MDR Report Key3628055
MDR Text Key21527481
Report NumberMW5034409
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 02/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other

Patient Treatment Data
Date Received: 02/10/2014 Patient Sequence Number: 1