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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 8065029501
Device Problem Failure to fire
Event Date 04/20/2007
Event Type  Malfunction  
Manufacturer Narrative

Reporting of this complaint at this time is based on receipt of a letter from the fda dated april 10, 2008 in which the agency informed alcon that complaint (event date: 2006) should have been reported as a serious injury mdr. As a result of that injury report, a 2-year reporting timeframe was initiated for all complaints of the same type. All complaint files were reviewed for this type of event starting. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation, the territory manager, (tm) performed 10 test surgeries, but could not duplicate the laser stopped firing issue. The tm was able to identify the event as reported in the surgery database. The tm replaced the thyratron as a preventative measure and completed a successful system verification. The returned thyratron was bench tested by manufacturing for six hours and the thyratron operated normally without error. Conclusion: based on this investigation, and the results of prior investigation, the event was consistent with normal behavior of the thyratron technology and the root cause is most likely related to the thyratron.

 
Event Description

A system operator reports the laser stopped firing during a procedure. The system operator hit ablate and the surgeon was able to complete the procedure without further interruption. The system operator stated the surgeon was satisfied with the patient's outcome and the pt was not harmed or injured.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer (Section G)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1074093
Report Number1061857-2008-00143
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/23/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065029501
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/27/2007
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/23/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2003
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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