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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
Event Date 09/14/2011
Event Type  Injury  
Event Description

The clinic reported that a pt treated for a laser vision enhancement procedure approx 4 years earlier presented with an epithelial ingrowth in the right eye. The epithelial ingrowth was removed on (b)(6) 2011. The pt returned on (b)(6) 2011 for a f/u examine due to experiencing blurriness in their right eye. The pt was diagnosed with a recurring epithelial ingrowth. The surgeon lifted the flap and removed the ingrowth. This is a recurring event for this pt and a similar event was reported on (b)(6) 2011 in medwatch 3006695864-2011-00058.

 
Manufacturer Narrative

(b)(4). Epithelial ingrowth. No clinical support or service was requested. Customer reporting incident only. 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.

 
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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 Key2339383
Report Number3006695864-2011-00109
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2011
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer09/29/2011
Date Manufacturer Received09/29/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/24/2011 Patient Sequence Number: 1
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