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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADAR6000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADAR6000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990007
Device Problem Failure to fire
Event Date 08/18/2006
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 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 reported problem, however, was able to identify the event as reported in the surgery database. The tm ran test surgeries and ran multiple surgery day performance tests, but found no problem. The tm replaced the digitizer as the most probable cause and performed a successful system verification. The returned part was tested by manufacturing and was found to be functioning properly. Conclusion: based on the results of this investigation, the root cause could not be definitively identified. This report mailed in to fda on: 07/09/2008.

 
Event Description

An ophthalmic technician reports the laser stopped firing after several shots were fired during surgery. The ophthalmic technician stated the procedure was aborted, the shot pattern reloaded and the laser still would not fire. The system was reset, the shot pattern reloaded and the surgeon was able to compete the procedure. The ophthalmic technician stated the surgeon was satisfied with the patient's outcome and the pt was not seriously injured by this event.

 
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Brand NameLADAR6000
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 Key1074104
Report Number1061857-2008-00140
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/18/2006
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 Number8065990007
OTHER Device ID Number6.1.2
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/24/2006
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/18/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2006
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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