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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISXVISX S4

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VISX VISX S4   Back to Search Results
Event Date 04/17/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

In 2007, i underwent lasik vision correction surgery. I was screened and declared a perfect candidate for the surgery. The surgery itself went exactly as planned with no "surgical" complications. According to the dr, the healing process also went normal and i was declared to have an excellent outcome due to my low refractive error. However, in spite of this, the results of this surgery were actually disastrous. Although my post-surgical refractive error is quite low, the surgery induced a significant level of higher order aberrations, including a highly abnormal level of spherical aberration and coma due to a correction zone that is much smaller than my scotopic pupil size. I see fine in direct sunlight and natural lighting, but have difficulty seeing clearly under normal levels of indoor or artificial lighting. I can not see clearly in many indoor environments during the day, particularly on overcast days, and i have consistently poor quality of vision indoors in the evenings due to significant loss of contrast sensitivity. I frequently experience halos around indoor lighting. It is also very difficult to drive at night due to significant starbursting on all light sources, which results in a significant loss of depth perception. I can not enjoy many leisure activities such as watching movies. Watching television with lights on can be quite challenging due to poor quality of the image i see, and going out at night is difficult. None of these vision quality issues can be reliably corrected with glasses or contact lenses, and when dealing with eye drs, i find that my pupils are now considered to be abnormal and i'm lumped in with individuals who have diseased corneas. Although i did sign an informed consent form, this form was treated as a formality and it was represented to me that with the latest wavefront technology, the types of complications detailed in that consent form were mostly a thing of the past. I also expected to be notified if i was at a higher risk for any of those complications -i. E. Due to my larger than average pupils, etc. , but was not adequately notified of my higher than average risk factors. I have spent a significant part of the last year trying to cope with the emotional turmoil and anxiety that have resulted from the loss of visual quality from an elective surgery that was supposed to improve my quality of life. I did not need this surgery, and based on my results, it clearly is not as safe and reliable as it was represented to be.

 
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Brand NameVISX
Type of DeviceVISX S4
Device Event Key1007116
MDR Report Key1037947
Event Key996308
Report NumberMW5006646
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/02/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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