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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 09/21/2006
Event Type  Malfunction  
Event Description

A system operator reported the laser stopped firing during a conventional surgery. A review of the surgery database indicated the site was able to complete the procedure during the same session with no further interruptions. At one week post-op, the system operator stated there were no complications with the patient.

 
Manufacturer Narrative

Reporting of this complaint is based on the receipt of a letter from fda dated april 10, 2008 regarding the fileability of complaint rs061048 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 system. He was unable to find any issue with the laser's performance that would cause the laser to stop firing and no parts were replaced. A successful system verification was performed. A review of the tracker information shows an interruption approximately 1/3rd of the way through the surgery. All other signals, including monitored energy levels, appear normal. Conclusion: based on the results of the investigation, a definitive root cause could not be determined.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
site 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1047065
Report Number1061857-2008-00060
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2006
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 Number8065490084
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/21/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/16/2003
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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