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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX S4 LASER STAR S4 IR LASER

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VISX VISX S4 LASER STAR S4 IR LASER Back to Search Results
Event Date 08/29/2003
Event Type  Injury  
Event Description

Lasik enhancement, 2 more subsequent enhancements, irregular astigmatism. Event abated after use stopped or dose reduced? 1. No, 2. No.

 
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Brand NameVISX S4 LASER
Type of DeviceSTAR S4 IR LASER
Manufacturer (Section D)
VISX
santa clara CA
MDR Report Key1081413
Report NumberMW5007786
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/23/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2008
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: 07/23/2008 Patient Sequence Number: 1
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