• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065029501
Device Problem Failure to fire
Event Date 11/04/2006
Event Type  Malfunction  
Event Description

A system operator reports the laser skipped firing (stopped firing) during the beginning of a procedure. The system operator was able to un-track, re-track, hit ablate and the surgeon was able to complete the procedure. The system operator stated the surgeon was satisfied with the patient's outcome and the patient was not injured by this event.

 
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 ladarvision4000 were reviewed for this type of event starting the same day. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation the field service engineer (fse) performed 10 test surgeries, but was unable to duplicate the laser not firing issue. As a preventative measure, the fse replaced the laser chassis and then completed a successful system verification. The returned part was bench tested by manufacturing and no problems were found. A quality engineer reviewed the surgery database and was able to identify the event as reported. Conclusion: based on this investigation and the results of prior investigations, the event was consistent with normal behavior of the thyratron technology and the root cause is most likely related to the thyratron.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key1065607
Report Number1061857-2008-00127
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2006
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065029501
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/10/2006
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/04/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-