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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 0030-2450
Event Date 07/17/2008
Event Type  Injury  
Manufacturer Narrative

Service not requested. Referred surgeon to medical monitor.

 
Event Description

Following a prk procedure, the doctor reported observing a "central island" in the patient's left eye.

 
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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 rd.
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1211624
Report Number3006695864-2008-00024
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number0030-2450
Device Catalogue Number0030-2450
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received09/25/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2003
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: 10/24/2008 Patient Sequence Number: 1
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