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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
Device Problem No Known Device Problem
Event Date 01/06/2011
Event Type  Injury  
Event Description

The customer initially contacted amo with advice on performing an enhancement on a pt. The clinic reported that the pt treated for laser vision correction presented at a 5 month post operative exam with a 2 line loss of best corrected visual acuity (bcva) in the right eye (od). The pt's pre-op bcva was 20/20 od and the pt's post-op is currently 20/30 bcva od.

 
Manufacturer Narrative

Field service on the equipment was not required. The amo clinical development manager (cdm) and the amo medical monitor reviewed the pt charts. The medical monitor recommended against further treatment and indicated that the pt's pre-op charts are suggestive of keratoconus. The clinic indicated that they would not perform any further treatment on this pt. No further info is available.

 
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Brand NameVISX EXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA, LLC
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 Key2176660
Report Number3006695864-2011-00061
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR
Device Catalogue Number0030-4864
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received06/15/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/1999
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: 07/13/2011 Patient Sequence Number: 1
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