• 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 8065490006
Device Problem Failure to fire
Event Date 10/26/2006
Event Type  Malfunction  
Event Description

A system operator reports the laser stopped firing at 99% into a procedure. The system operator hit the ablate button numerous times and then was able to complete the surgery. The system operator stated the surgeon was satisfied with the patient's outcome and the pt 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) completed two test surgeries and completed surgery day performance testing, but was unable to duplicate the reported laser stopped firing issue. The fse did identify the event in the surgery database and completed a successful system verification. No parts were replaced or returned for eval. 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 dr.
suite 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 Key1065609
Report Number1061857-2008-00126
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2006
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 Number8065490006
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/26/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/05/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-