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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 LASER
Event Type  Injury  
Event Description

The surgeon reported experiencing sporadic slight decentration in patients following laser vision correction and approximately 10% of all patients are undercorrected, due to corneal haze. The number of patients and the severity of the outcomes were not provided.

 
Manufacturer Narrative

The equipment was examined and tested by an amo clinical development specialist at the clinic location. The excimer laser, wavescan and femtosecond laser were found to be operating properly. The cause of doctor's report of random haze was not able to be determined.

 
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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 Key1449404
Report Number3006695864-2009-00074
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 05/11/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSTAR S4 IR LASER
Device Catalogue Number0030-1479
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 Received05/11/2009
Was Device Evaluated By Manufacturer? Yes
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: 08/19/2009 Patient Sequence Number: 1
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