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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON-ORLANDO TECHNOLOGY CENTER LADAR6000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON-ORLANDO TECHNOLOGY CENTER LADAR6000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990007
Device Problem Failure to fire
Event Date 09/07/2008
Event Type  Malfunction  
Event Description

A surgeon reports that during system calibration, the laser fired slower than normal. Then, the system would not fire at the beginning of a procedure. The surgeon stated he untracked the pt, re-tracked, hit ablate and was able to proceed without further issue. The surgeon stated the pt was not seriously injured or impacted 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 ladar6000 were reviewed for this type of event starting event date. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: during the on-site investigation, the territory manager, (tm) was unable to duplicate the slower than normal firing rate during volume per shot (vps) calibration test. The tm performed multiple vps calibration tests, including tests following test surgery without duplicating the slow firing issue. During test surgery, the test target was manually rotated, the foot switch was disengaged, the horizontal reference line was repositioned and the test surgery resumed with no problem. The laser not firing issue could not be duplicated. No parts were replaced or returned for eval. A successful system verification was performed. The surgery database was reviewed and only 1 footswitch interruption was noted during this procedure. Conclusion: based on the results of this investigation, the root cause could not be definitively identified.

 
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Brand NameLADAR6000
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.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1074102
Report Number1061857-2008-00142
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990007
OTHER Device ID Number6.4.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/07/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2006
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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