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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK SURGERY LASER

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PRK SURGERY LASER Back to Search Results
Event Date 08/28/2007
Event Type  Injury  
Event Description

Severe dry eyes after prk surgery. To start off with, i am a physician in practice for 4 years and am well read and have a high level of medical understanding, and voluntarily chose to have prk surgery. I was made aware of potential se, but had no idea how bad they could be. Having never tried contacts, i spoke with a recommended ophthalmologist who recommended prk, a similar procedure to lasik, and done with the same laser. I was excited at the idea of perfect vision -i now have 20/15 b/l vision-, and although i did read up on the procedure on the internet and the information he gave me, it seemed like a no-brainer. In retrospect, i feel the potential negative outcomes are downplayed but if you are one of those unlucky enough to get them, you'll wish you never had the surgery, as i do. So, the problem. I had the surgery in 2007 and severe pain afterwards for about 1-2 weeks. After that, things seemed to get better, but i did have dry eyes for the next six months. I thought and was led to believe that i was out of the woods when about 16 months later, in 2009, i had severe dry eyes in which my eyelids stuck to my eyeballs every time i would awake in the am. My corneas would get damaged from the epithelium being ripped off. This damage was confirmed on exam by my ophthalmologist. I want to be very clear here, in my entire life, had problems with dry eyes, and there is no family history either. The next month or two were hell and i was literally afraid to go to sleep, dreading the excruciating pain i knew would come when i would wake. My doctor tried to say this had nothing to do with the surgery, and i think that this is ridiculous, and he eventually acknowledged the likely relationship. I ended up trying numerous different eye drops, including restasis, using a humidifier, sleeping without heat, having protective contacts placed on my eyes, and getting upper and lower plugs placed in my tear ducts. When the summer came, with the higher humidity, things were better, but now that the winter's here again, i'm again experiencing dry eyes. We did find one product that helped, and no i have nothing to do with the company that makes it- and i have to goop my eyes with this product every night to prevent my eyelids from sticking to my eyeballs, though thankfully this does work. I never reported this to the fda in the past, and don't know if my ophthalmologist did, but i would never recommend this surgery to anyone and certainly wouldn't have gone through with it if i knew this could happen. In addition, i think it was inappropriate for my surgeon to recommend the surgery before recommending that i try contacts, and i wonder how much of this has to do with the fact that he just bought the machine and is more than happy to cut on people's eyes if they're willing to pay, which i was. Mfr name, city and state: i don't know, but i don't think this is the issue. The problem is with the procedure, not the laser.

 
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Brand NamePRK SURGERY LASER
Type of DevicePRK SURGERY LASER
MDR Report Key1559401
Report NumberMW5013910
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2009
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? Yes

Patient TREATMENT DATA
Date Received: 12/09/2009 Patient Sequence Number: 1
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