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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, ETL
Event Date 03/13/2008
Event Type  Injury  
Event Description

The doctor reported experiencing cses of dlk (diffuse lamellar keratitis) in some of his pts following refractive treatments. The number of pts and dates of procedures were not known. No specific information was provided. It was reported that the severity of cases of dlk range from stage 1 to stage 4. During the onsite investigation, the amo clinical specialist reported that one pt being examined presented with stage 4 dlk and corneal melt following a lasik procedure. All cses of dlk have reportedly resolved.

 
Manufacturer Narrative

During the onsite investigation, it was observed that the recommended cleaning instructions for the microkeratome were not followed. According to the physician the cause of the events is believed to be the gloves used during the surgeries. The clinic change the brand of gloves and no further cases of dlk have been reported. Equipment service was not performed; however, procedures were observed and no issues were noted with the operation of the laser.

 
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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 Key1386944
Report Number3006695864-2009-00038
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/13/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSTAR S4, ETL
Device Catalogue Number0030-4077
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 Received03/13/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2006
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: 05/14/2009 Patient Sequence Number: 1
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