• 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 Unknown (for use when the device problem is not known)
Event Date 08/10/2006
Event Type  Injury  
Event Description

A system operator reported the laser stopped firing during calibration prior to the next procedure. The pt's flap had been cut and they were unable to proceed with the surgery. The pt was re-scheduled for the procedure and the system operator indicated the pt was "doing well" following the surgery. The surgeon stated the patient was not harmed or injured by this event. Additional information provided indicated the patient's bcva in the right eye decreased one line from 20/15 to 20/20-1 at one month post-op.

 
Manufacturer Narrative

Reporting of this complaint is based on receipt of a letter from fda dated april 10, 2008 regarding the fileability of complaint determined to be an injury and another complaint 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 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 7/10/2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: the filed service engineer (fse) was dispatched to the site to evaluate the system. The fse confirmed the laser not firing and replaced the laser chassis assembly. He completed a systems verification prior to departure. The returned part was tested by manufacturing and found to have an open heater coil in the thyratron. This would cause the laser to not fire. The patient exhibited a 1 line decrease in bcva however, this may not represent a true decrease as it may be associated with variation in testing techniques. Conclusion: based on the investigation results, the root cause of the reported difficulty was related to an open heater coil in 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 Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1047302
Report Number1061857-2008-00055
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/10/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2008
Is This An Adverse Event Report? Yes
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
Date Returned to Manufacturer08/21/2006
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/10/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/16/2008 Patient Sequence Number: 1
-
-