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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065490084
Device Problem Failure to fire
Event Date 10/03/2006
Event Type  Malfunction  
Event Description

A system operator reported the laser stopped firing during ablation on 1 patient. She re-tracked the patient, hit ablate and the surgeon was able to proceed without further interruption. The system operator stated the surgeon was satisfied with the patient's outcome, and the patient was not injured by this event.

 
Manufacturer Narrative

Determination of root cause: assessment: the field service engineer (fse) was dispatched to the facility to evaluate the system. The fse could not duplicate the reported problem; however, he did confirm an interruption occured within the database as a footswitch pause. The fse replaced the footswitch and digital i/o printed circuit board assembly as a preventative measure and completed a system verification. The returned parts were tested and the reported problem could not be duplicated. Both parts passed all testing. Conclusion: based on the results of the investigation, the root cause of the reported difficulty is most likely due to the surgeon inadvertently lifting his foot off the footswitch during surgery.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1047144
Report Number1061857-2008-00061
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/03/2006
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065490084
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/12/2006
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/03/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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