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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING VISX LASER EXCIMER LASER

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

Unable to evaluate, info is not available to identify the device. No evidence of equipment malfunction.

 
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Brand NameVISX LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING
510 cottonwood dr.
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING
510 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1075233
Report Number1221842-2008-00005
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 Received06/20/2008
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 Report TO Manufacturer05/14/2008
Date Manufacturer Received05/23/2008
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: 06/20/2008 Patient Sequence Number: 1
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