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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 UNKNOWN
Event Date 01/01/2001
Event Type  Injury  
Event Description

A review of the maude database revealed the following voluntary report from a patient: the patient reported experiencing severe dry eye requiring punctal plugs and doxycycline therapy. In 2007, the patient reported being diagnosed with "post-lasik ectasia" and irregular astigmatism.

 
Manufacturer Narrative

Product, clinic and reporter are unknown. Ectasia.

 
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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 Key1403431
Report Number3006695864-2009-00049
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received05/18/2009
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/08/2009 Patient Sequence Number: 1
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