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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 09/25/2006
Event Type  Malfunction  
Event Description

A system operator reported the laser stopped firing 3 times on 1 patient. On each occasion, he was able to hit ablate and continue. The surgeon was able to complete the procedure within the same surgical session. The surgeon stated he was satisfied with the patient's outcome, and the patient was not injured by this event.

 
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 determined to be an injury determined to be a reportable malfunction per the 2-year rule. As a result of this fda letter, all complaint files for the ladarvision 4000 and ladar6000 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 in 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 system. A review of the database showed the laser was interrupted by the footswitch and he was unable to re-produce the reported problem. The fse performed a successful system verification and discussed the database evidence with the surgeon regarding issues where the laser stopped firing due to the surgeon's foot slipping off the footswitch. Conclusion: based on the results of the investigation, the root cause of the laser not firing in this instance appears to have been the surgeon's foot slipping off the footswitch.

 
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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 Key1047141
Report Number1061857-2008-00057
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/25/2006
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 Received09/25/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2001
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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