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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX EXCIMER LASER

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VISX EXCIMER LASER Back to Search Results
Event Date 07/06/2006
Event Type  Injury  
Event Description

I was overcorrected in my left eye as a result of wavefront prk with the visx excimer laser. Not only that i have, terrible side effects in both eyes -gash- which greatly affect my night vision and vision in low light situations. Mild dry eye is also problematic. For a procedure that was supposed to make my life easier, it has made it much more difficult and complex on a daily basis. I so very wish that i could go back to my vision with glasses. Not a day goes by that i am not reminded of the adverse events following my prk. Date of use: 2006. Diagnosis or reason for use: myopia. Event abated after use stopped or dose reduced? #1. No, #2. No.

 
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Brand NameVISX
Type of DeviceEXCIMER LASER
MDR Report Key1039122
Report NumberMW5006731
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2008
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? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/05/2008 Patient Sequence Number: 1
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