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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 8065029501
Device Problem Failure to fire
Event Date 07/14/2006
Event Type  Malfunction  
Manufacturer Narrative

Reporting of this complaint is based on 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 and the 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 facility to evaluate the device. Review of the instrumentation database indicated the laser was not firing. The fse ran the system for 3 hours and performed multiple test surgeries and could not reproduce the laser not firing condition. The fse then checked all connectors and voltages and all were within specification. A system verification was completed. Conclusion: based on the investigation results, the root cause of the reported difficulty could not be determined.

 
Event Description

The site reported the laser stopped firing during calibration between pts. The system was reset and the system passed calibration. On the next procedure, after the pt's flap had been cut, calibration was run and the laser would not fire. They were unable to proceed with the procedure and the pt's surgery was rescheduled for the following week. Add'l info provided indicated, the surgeon felt the pt was not harmed or injured by this event.

 
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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 Key1047080
Report Number1061857-2008-00054
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2006
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 Number8065029501
OTHER Device ID Number5.14
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received07/14/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2002
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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