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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 03/07/2007
Event Type  Injury  
Event Description

Received lasik eye surgery on my right eye. Prior to my appointment i had many scans from the tlc ctr on my right eye. I had all the required pre-op appointments. The day of my surgery, the doctor put the ring around my eye. The device was off ctr and had to be adjusted and put back on. My eye ball swelled and i had a large red ring where the device was. The lasik was performed. Outcome was good. Two months later, i awoke to great pain in my right eye. Later that morning, i noticed that i was missing vision from the ctr of my eye up. I was like someone pulled a shade over half my eye. I went to the eye doctor for my follow up visit, and i mentioned this new development. My retina detached. I had to see a specialist for a scleral buckle. This reattached my retina. However, i no longer have 20/20 vision in my right eye. I was told they can reperform the lasik to recorrect my vision. After all that, i went through i do not think i will have it redone. I have since gone into a deep depression and now i am being treated for that. I still have to see the retinal specialist for check up. I have very poor night vision in my right eye. In the paper work, i signed for the surgery for lasik procedure it did say that there was a possibility of detached retina, however, i did not understand what that meant.

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Type of DeviceLASIK
MDR Report Key1037786
Report NumberMW5006572
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
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

Date Received: 05/01/2008 Patient Sequence Number: 1