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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX 4 EXCIMER LASER NONE

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VISX 4 EXCIMER LASER NONE Back to Search Results
Event Date 09/22/2006
Event Type  Injury  
Event Description

Lasik complication. Following a lasik procedure i developed inflammation and central toxic keratopathy -ctk- resulting in severe hazing across the cornea, arge straea, and a blistering of the epithelial layer. Betadine was administered even though i reported an allergy to it. Hazing cleared, but halos in day time reflections and night time lights are prevalent in both eyes. I am now 4 steps farsighted -was 3. 5 steps near sighted- in one eye. Irregular astigmatism persists causing ghost images and fuzzy vision. I believe this to be a permanent condition after nearly 2 years.

 
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Brand NameVISX 4 EXCIMER LASER
Type of DeviceNONE
MDR Report Key1075511
Report NumberMW5007633
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2008
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

Patient TREATMENT DATA
Date Received: 07/12/2008 Patient Sequence Number: 1
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