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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/06/2011
Event Type  Injury  
Manufacturer Narrative

The field service engineer inspected the equipment at the customer location and performed routine calibrations. The field service engineer could not find any issues with the equipment that related to the pt outcome. All pertinent info available to amo has been submitted. Should new info that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted.

 
Event Description

The clinic reported that a laser vision correction pt presented at the 5 day post-op examination with an overcorrection in both eyes and a loss of best corrected visual acuity (bcva). The pt's bcva in the right eye is 20/40 and the bcva in the left eye is 20/30.

 
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Brand NameVISX EXCIMER 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 place
santa ana , CA 92705-4933
7142478598
MDR Report Key2338616
Report Number3006695864-2011-00112
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/11/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-1479
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Outpatient Treatment Facility
Date Manufacturer Received10/11/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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