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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC VISX EXCIMER LASER

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AMO MANUFACTURING USA, LLC VISX EXCIMER LASER Back to Search Results
Event Type  Injury  
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Brand NameVISX EXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA, LLC
510 cottonwood dr
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING, USA, LLC
510 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e st. andrew pl
santa ana , CA 92705-4933
7142478598
MDR Report Key1088663
Report Number3006695864-2008-00008
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report?
Device Operator Health Professional
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2008
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/25/2008 Patient Sequence Number: 1
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