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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 10/26/2006
Event Type  Malfunction  
Event Description

A system operator reports the laser stopped firing during a procedure. The system operator was advised by technical service support to abort the procedure and restart the surgery. This was successful and the procedure was completed. No further information was provided by the facility.

 
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 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation, the field service engineer (fse) was unable to duplicate the laser not firing issue; however, the fse did identify the event in the surgery database. No parts were replaced or returned for evaluation and a successful system verification was performed. Additional information was requested on 10/31/2006. 11/01/2006, 11/06/2006, and a questionnaire was sent on 11/07/2006. We have received no response to date. 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. This report mailed in to fda on: 06/24/2008.

 
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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 CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1065604
Report Number1061857-2008-00125
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2006
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 Number8065490084
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/26/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2001
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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