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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
Model Number STAR S4 IR CE
Event Type  Injury  
Manufacturer Narrative

An amo field service technician examined the system and all parameters were within specification.

 
Event Description

The surgeon reported an over-correction in a pt treated for lasik vision correction. Further pt details have been requested but have not been received. The clinic is reluctant to provide additional info.

 
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Brand NameVISX EXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1585825
Report Number3006695864-2009-00122
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR CE
Device Catalogue Number0030-4966
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Outpatient Treatment Facility
Date Manufacturer Received12/23/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2007
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: 01/20/2010 Patient Sequence Number: 1
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