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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER SURGERY

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LASER SURGERY   Back to Search Results
Event Date 09/29/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

I had prk surgery (b)(6) 2011 at the (b)(6). I was told i would be back to work 6 days later with close to corrected vision. I came back for my four day check up, they took the contacts out of my eyes. I was told it would feel a little gritty for a couple of days. I didn't make it fifteen minutes down the road and i felt like i had razor blades underneath my eyelids. Being in the military, i manned up the best i knew how, put way more than prescribed numbing drops and took multiple narcotic pain pills. None of this worked. I got a hold of my surgeon and told him i would try and hold out until the next day. It was the worst pain i have ever experienced in my life. The next day i went down and they said my eyes had "sluthed. " they put the contacts back and for approx two more weeks, waiting for an 8mm abrasion on both of my eyes to heal up - the civilian ophthalmologist noticed these abrasions, right before my surgeon came and looked at my eyes, and overlooked them! the abrasions never healed up, so they patched my eyes for a week and a half a piece and the abrasions finally healed up, leaving behind a lot of scar tissue, which i am still dealing with now. I've been on a long dose of steroids and i am still tapering off of them, and yet the scarring still has not gotten any better. I volunteered for this surgery to make my life better, easier, and more mission ready for my certain career field in the (b)(6). It was placed to my understanding that this was a fairly quick and short term healing procedure. But i am supposedly one of the thousands of select people that this happens to. I was told that after the six month period from my surgery, if this scarring was not healed that i could opt for the surgery again or just deal with it.

 
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Type of DeviceLASER SURGERY
Device Event Key2403317
MDR Report Key2381345
Event Key2278201
Report NumberMW5023463
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2011
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? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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