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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 05/11/2007
Event Type  Malfunction  
Event Description

A clinical application specialist observed the laser stopped firing during surgery. The system operator was able to abort the procedure, reloaded the shot pattern and the surgeon was able to complete the surgery. During follow-up with the system operator stated the surgeon was satisfied with the patient's outcome and the pt was not harmed or injured by this event.

 
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 for the ladar6000 were reviewed for this type of event starting 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation, the territory manager, (tm) was unable to duplicate the report laser stopped firing, but was able to identify the event as reported in the surgery database. The tm performed a thyratron optimization and a successful system verification. No parts were replaced or returned for eval. Conclusion: based on this investigation and the results of prior investigations, the event was consistent with normal behavior of the thyratron technology and the root cause is most likely related to the thyratron. This report mailed in to fda on: 07/09/2008.

 
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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 Key1074094
Report Number1061857-2008-00139
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2007
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 Number8065490084
OTHER Device ID Number5.5.0, CSPS
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received05/11/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2004
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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