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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING VISX STAR S4 IR EXCIMER LASER

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AMO MANUFACTURING VISX STAR S4 IR EXCIMER LASER Back to Search Results
Model Number STAR S4 IR
Device Problem Normal
Event Date 01/14/2008
Event Type  Injury  
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Brand NameVISX STAR S4 IR EXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING
310 cottonwood dr
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING
310 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e st andrew pl
santa ana , CA 92705-4933
7142478598
MDR Report Key1066093
Report Number1221842-2008-00019
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/14/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-1479
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2008
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer03/14/2008
Date Manufacturer Received03/14/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/1997
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/20/2008 Patient Sequence Number: 1
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