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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX EXCIMER LASER

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VISX VISX EXCIMER LASER Back to Search Results
Event Date 06/10/2007
Event Type  Injury  
Event Description

Visx excimer laser was used, had lasik eye surgery performed using the "wavefront" technology -an upsell- on both eyes. Six months later, the surgery was redone on the right eye which needed a "touch up". The warranty on the service was 1 year. After 14 months, i was told that the surgery was a failure and that i would continue to need glasses. This came after enough "follow-up" visits to get me outside the warranty period even though the prescription never got any better or worse. More importantly, i have suffered a massive drying of the eyes since the surgery in both eyes. The dryness gets to the point of making my eyes blurry later in the night and no type of eyedrops or punctal plugs have been able to satisfy the issue.

 
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Brand NameVISX EXCIMER LASER
Type of DeviceNA
Manufacturer (Section D)
VISX
MDR Report Key1515390
Report NumberMW5013142
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/20/2009 Patient Sequence Number: 1
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