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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 08/10/2006
Event Type  Malfunction  
Manufacturer Narrative

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 07/10/2006. Determination of root cause: assessment: the field service engineer (fse) was dispatched to the site to evaluate the system. He was unable to determine the reason for the reported difficulty; no parts were replaced or returned. A successful system verification was performed prior to departure. Conclusion: based on the results of the investigation, a definitive root cause could not be determined.

 
Event Description

A system operator reports the laser stopped firing during surgery two times in the last 3-4 months. Follow-up with the site indicated the surgeons could not remember patient names, but there had been no complications with any patients. No further information was provided.

 
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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 Key1047066
Report Number1061857-2008-00063
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2006
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 Number5.14
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received08/30/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2002
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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