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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 08/10/2006
Event Type  Malfunction  
Event Description

A system operator reported during ablation at approximately 39% complete, the laser stopped firing. Several attempts were made to re-start the ablation, but were unsuccessful. The system was reset, the procedure re-loaded and the surgeon w as able to complete the procedure without further interruption. The surgeon stated he was satisfied with the patent's outcome and the patient was not seriously injured by the event.

 
Manufacturer Narrative

Reporting of this complaint is based on the receipt of a letter from fda dated april 10, 2008 regarding the fileability of complaint determined to be an injury and determined to be a reportable malfunction per the 2-year rule. As a result of this fda letter, all complaint files for the ladarvision 4000 and ladar6000 products were reviewed. Based on the criteria for filing set forth in this letter, alcon established a new 2-year reporting rule for this type of event, starting 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: the field service engineer (fse) was dispatched to the site to evaluate the system. The fse confirmed the issue and found the thyratron was pre-firing and adjusted the thyratron to address the problem. The fse then performed a system verification. Conclusion: based on the investigation results, the root cause of the reported difficulty was 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 drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1047064
Report Number1061857-2008-00056
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/14/2006
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065490084
OTHER Device ID Number5.2.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/14/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/29/2002
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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