• 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 LADARVISION4000 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 LADARVISION4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065040601
Device Problem Failure to fire
Event Date 11/16/2007
Event Type  Malfunction  
Event Description

A surgeon reports that during a procedure, the laser would not fire and no error message was displayed. The procedure could not be completed at that time. Additional information from the surgeon indicates something was wrong during calibration, the laser fired only from time to time, but despite the 'erratic functioning', he decided to proceed with the surgery. Follow-up information from the site corrected the earlier statement of not seeing an error message, the error message was displayed. A questionnaire was received from the site and indicated the patient's treatment was completed 8 days later, and there was no harm to the patient.

 
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 on 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) was able to duplicate the intermittent laser not firing issue. The laser was only emitting a short pulse after which the laser would not fire, but the thyratron was still switching. The fse determined the laser cartridge internal fan was faulty and replaced the laser cartridge, then performed a successful system verification. The returned part was tested by manufacturing and found to fire intermittently. Examination of the internal fan revealed the fan shaft was turning the correct direction and approximate rpm; however, it appears the fan was decoupled from the motor. Conclusion: based on the investigation results, the root cause is a faulty internal fan on the laser cartridge.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLADARVISION4000
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 Key1064665
Report Number1061857-2008-00116
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065040601
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/19/2007
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/20/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/28/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-