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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 8065490006
Device Problem Failure to fire
Event Date 06/21/2007
Event Type  Malfunction  
Event Description

System operator reported the laser would not fire at the beginning of a procedure. Follow-up with the ophthalmic technician indicates the surgeon stepped on the footswitch to start a procedure, and the laser would not fire. The ophthalmic technician aborted the procedure, calibrated the system and reloaded the shot pattern. The surgeon was then able to complete the procedure in the same surgical session without interruption. The ophthalmic technician stated the surgeon felt 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 the same day. 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 test surgery and several ablations, but was unable to reproduce the laser not firing issue. A surgery day performance test was run and the system performed to specifications. No parts were replaced or returned for eval. 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.

 
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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 Key1074095
Report Number1061857-2008-00138
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/21/2007
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 Number8065490006
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/21/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2000
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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