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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX LASIK DEVICE

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VISX LASIK DEVICE Back to Search Results
Event Date 11/13/2007
Event Type  Injury  
Event Description

Custom wavefront lasik both eyes. Initial outcome: remarkable improvement in vision. Deterioration noted after 3-4 days. Problem with multiple images immediately following procedure, esp. At night. Dry eye. Distinct difference in prescription between left and right eyes after surgery. Right eye was retreated after 9 months and is now near sighted only. Dr. Advised against retreat on left eye -for fear of same outcome?- when i look at the moon or a traffic light i see 5 images. The additional images are in the same positions in both eyes. This leads me to believe something was wrong with the equipment or setup -visx- several wavescans have been attempted by 3 doctors/machines since surgery on the right eye with no success.

 
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Brand NameVISX
Type of DeviceLASIK DEVICE
MDR Report Key1662665
Report NumberMW5015580
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 04/14/2010 Patient Sequence Number: 1
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