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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC VISX STAR EXCIMER LASER

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AMO MANUFACTURING USA, LLC VISX STAR EXCIMER LASER Back to Search Results
Model Number STAR S4
Event Date 11/11/2003
Event Type  Injury  
Manufacturer Narrative

A review of our records was conducted and no report was rec'd that matches or resembles the report from the pt. Our svc records revealed that the clinic requested a svc on the laser on the same day as the pt's treatment. The svc request was for low transmission and intermittent reticle. This issue with the laser would not have caused or contributed to the pt's experience. The field svc engineer replaced a lens an calibrated the sys.

 
Event Description

Pt reported severe dry eye with visual disturbances and loss of contrast sensitivity in both eyes following a lasik procedure.

 
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Brand NameVISX STAR EXCIMER LASER
Type of DeviceEXCIMER 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 Key1164956
Report Number3006695864-2008-00013
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 08/04/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4
Device Catalogue Number0030-1479
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1999
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: 09/08/2008 Patient Sequence Number: 1
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