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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXCIMER LASER FOR LASIK AND PRK

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EXCIMER LASER FOR LASIK AND PRK Back to Search Results
Event Date 01/01/1999
Event Type  Injury  
Event Description

Pt was told he was the perfect candidate when he first had lasik in 1999 followed by five surface ablation "tune ups" using prk on his right eye. Ultimately the pt required a corneal transplant in his right eye because of ectasia. The transplant surgery was performed by a world renowned refractive surgeon, yet the pt's results were less than adequate and he was enhanced twice in his transplant eye via lasik without improvement in vision. Pt also developed ectasia in his left eye and was treated in that eye with a corneal transplant as well. In 2007, pt was told in consultation with another renowned refractive surgeon that his vision could be fixed with intacs, but this was not the case, and the intac surgeries have left him even more visually impaired. Currently the pt has fluctuating vision on a daily basis with unaided acuity of 20/800. He is unable to see road signs and cannot drive either in the day or at night. Pt has profound night time visual disturbances of starbursts, glare and haloes. Pt had no prior history of depression, yet became suicidal with his outcome. Multiple attempts at rehabilitation with rigid lenses have been unsuccessful because of dry eye and pt discomfort. Pt remains unable to work. Pt now expresses considerable regret that he allowed his surgeon to "talk him into" having lasik performed over a donor graft.

 
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Type of DeviceEXCIMER LASER FOR LASIK AND PRK
MDR Report Key1510242
Report NumberMW5013015
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/14/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 10/14/2009 Patient Sequence Number: 1
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