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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 8065040601
Device Problem Failure to fire
Event Date 01/04/2008
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 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 evaluate the device and found the system would not come out of 'laser not ready' state. He found no power to the high voltage power supply (hvps) due to a loose p1 connector between the hvps and the laser control electronics. He reseated the connector and completed a system verification prior to departure. Conclusion: based on the results of the investigation the root cause of the reported difficulty was due to a loose connector. This report mailed in to fda on: 06/12/2008.

 
Event Description

A nurse reports the laser stopped firing 13% into a procedure and an error message, laser not ready, was displayed. The surgery could not be completed. Follow-up info from the reporter indicates the pt's surgery was completed the following week and the pt was not harmed or injured by the event.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1060011
Report Number1061857-2008-00071
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/04/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065040601
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/04/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2001
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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