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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MFG VISX EXCIMER LASER

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AMO MFG VISX EXCIMER LASER Back to Search Results
Event Type  Injury  
Manufacturer Narrative

Unable to evaluate, info is not available to identify the device. Event unlikely to be related to a laser malfunction, however, data insufficient to determine.

 
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Brand NameVISX EXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
AMO MFG
510 cottonwood dr
milpitas CA 92705 493
Manufacturer (Section G)
AMO MFG
510 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1074398
Report Number1221842-2008-00011
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2008
Device Operator Health Professional
Was the Report Sent to FDA? No
Date Report TO Manufacturer05/22/2008
Date Manufacturer Received06/03/2008
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

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