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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 02/28/2007
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 ladarvision4000 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 field service engineer performed 6 test surgeries, but was unable to duplicate the laser not firing; however the fse was able to identify the event in the surgery database. The fse optimized the thyratron and completed a system verification. No parts were replaced or returned for evaluation. 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.

 
Event Description

A system operator reports the laser stopped firing about 90% into a procedure. The surgeon released the footswitch, depressed it again and was able to complete the procedure. Additional information provided at a later date indicated, the procedure was not completed on this patient. The remaining shots were fired onto test paper. However, the system operator stated the surgeon was satisfied with the patient outcome and the patient was not impacted or injured.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CTR
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1065592
Report Number1061857-2008-00111
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2008
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, CSPS
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/01/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberAN

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