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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 07/09/2007
Event Type  Injury  
Event Description

I underwent lasik surgery to correct farsightedness. I was initially corrected with monovision. I was unable to see clearly from that day on. I was told that it would take time for my eyes to heal and make the adjustments for the monovision. So, i waited patiently but the vision did not improve, instead it only got worse. In 2007, i was given an enhancement to "delete" the monovision - that is what the practice called the procedure. I had explained on numerous occasions that i felt something had gone terribly wrong. I was given the same song and dance every time i called in. When the flap was being cut in my right eye they stopped mid procedure and started again without explanation. I was told that this is no cause for alarm, but i am hesitant now to trust anything they say or do. I am left with scar tissue on my right eye that extends from the mid iris area to the edge of the pupil and a little bit beyond. My distance vision in both eyes was excellent before the procedure. Now i am left with blurry vision in my left eye and my right eye is similar to looking through a kaleidoscope. It is always very dry and painful, even though i put drops in as directed. My night vision requires such a heavy prescription that it distorts everything around me, causing me to fear going out at night. My right eye no longer opens completely because of the sensitivity to light and dryness. The depression following this event has been the most devastating event in my life so far. I am not sure where to turn for help, and am unable to think clearly to even follow through and get some help. When i call around for a second opinion i am told that i need to keep seeing my original surgeon, and that makes no sense. I can tell that my eye is getting worse, and i am certain that one day soon i will be unable to see at all with my right eye.

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Type of DeviceLASIK
MDR Report Key1069890
Report NumberMW5007530
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/06/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 07/06/2008 Patient Sequence Number: 1