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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 12/21/2006
Event Type  Injury  
Event Description

A system operator reports the laser stopped firing approximately 13% into a prk procedure and the surgeon was unable to complete the surgery. The system operator indicated the surgeon planned to wait 3 months until the patient was stable and then retreat. At 3 days post-op, the patient's ucva improved from 20/80 to 20/25. At 6 days post-op the ucva was 20/40. Follow-up information provided by the system operator indicated the patient's enhancement procedure was completed approximately 11 months following the date of the initial procedure. The patient's bcva prior to the enhancement was the same as pre-op initial surgery and the ucva at 4. 5 months post-enhancement was 20/15 with a plano refraction. The system operator stated the surgeon felt the patient 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 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: the field service engineer (fse) was dispatched to the site to evaluate the device. The fse observed intermittent laser not firing at thyratron voltage about 4. 8v. The fse replaced the chassis and the laser cartridge as a preventive measure, performed thyratron optimization and a system verification was completed successfully. The returned parts were tested by manufacturing. Manufacturing identified a resistor that mounts to the chassis housing was arcing to the capacitor bank which resulted in the laser not firing event. Conclusion: based on the investigation results, the root cause was component related, specifically the laser chassis. This report mailed in to fda on: 06/11/2008.

 
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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 Key1059112
Report Number1061857-2008-00078
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2006
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/11/2008
Is This An Adverse Event Report? Yes
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
Date Returned to Manufacturer01/04/2007
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/21/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/28/2002
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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