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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY

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LASIK EYE SURGERY Back to Search Results
Event Date 06/01/2006
Event Type  Injury  
Event Description

I am reporting the negative results of lasik surgery on my eyes. Immediately following the surgery, i experienced a precipitous loss of "near vision", i. E. The ability to see objects close to me. The radius of my lost "near vision" has continued to grow over the past three + years and now extends to approx four feet from my face. I have no genetic history that would explain the sudden and continued loss of my reading vision. Additionally, i now experience frequent headaches from the constant effort of trying to focus my eyes from near to distant objects. I experience mild discomfort in my right eye periodically, as if an eyelash was in my eye. Most disturbing to me is the damage to my peripheral vision: if i look at something out of the corners of my eyes, i experience severe double vision and dizziness. This was not something i had prior to lasik surgery, but presented immediately following the surgery. Finally, after all the expense and side-effects of lasik, the astigmatism i had sought to correct was not corrected and the benefit of improved distance vision has dissipated over time. Frequency: 1x. Route: ophthalmic. Dates of use: 2006 - 2010. Diagnosis or reason for use: astigmatism, mild myopia. Event abated after use stopped: no.

 
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Brand NameLASIK EYE SURGERY
Type of DeviceLASIK EYE SURGERY
MDR Report Key1577576
Report NumberMW5014288
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/08/2010 Patient Sequence Number: 1
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