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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 01/31/2008
Event Type  Injury  
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 ladarvision 4000 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 technical manager (tm) was dispatched to the site to evaluated the device. The tm found an open heater element on the thyratron, replaced the laser chassis (which contains the thyratron) and completed a system verification. Mfg tested the laser chassis and verified the tm's findings, an open heater circuit on the thyratron which will cause the laser to not fire. Conclusion: based on the results of the investigation, the root cause is component related, specifically an open heater coil on the thyratron. This report mailed in to fda on: 06/06/2008.

 
Event Description

A system operator reports the laser stopped firing at 23% into a procedure. The surgery could not be completed. Follow-up info from the system operator indicates there was no decrease in bcva, however, the pt started at -6. 00 diopter sphere and is now -4. 25 diopter. The pt will be re-evaluated in 3 mos. Follow-up with the system operator indicates the pt was re-treated on a different mfr's laser approx 3 mos following the initial procedure. Prior to the re-treatment, the pt exhibited a 1 line decrease in bcva. Additional info has been requested.

 
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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 Key1057423
Report Number1061857-2008-00101
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2008
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 Manufacturer02/06/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/07/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/23/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/06/2008 Patient Sequence Number: 1
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