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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 01/05/2007
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 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) found the tracker signals were low. He increased the tracker energy, balanced signals and completed all associated tests including a successful system verification. No parts were replaced or returned for eval. A review of the surgery database by a quality engineer found the system was interrupted by the tracker at 96% completion and the surgery session was terminated by a manual abort. This indicates the event was related to a tracking issue, it is known that when the tracker signals are low, the laser will stop firing. Conclusion: based on the investigation results, the root cause of the reported issue is component related, specifically a low tracking signal. This report mailed in to fda on: 07/09/2008.

 
Event Description

A system operator reports the laser stopped firing approximately 97% into a procedure. Several attempts were made to re-acquire, but all were unsuccessful and the procedure could not be completed. During follow-up, the surgeon stated he was completely satisfied with the patient's outcome and the pt was not harmed or 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
8175516810
MDR Report Key1074100
Report Number1061857-2008-00136
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2007
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 Number8065990007
OTHER Device ID Number6.4.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/11/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2006
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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