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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CTR. LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CTR. LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065030501
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 03/28/2008
Event Type  Malfunction  
Event Description

A nurse reports a pt with a possible decentered ablation. This report is for the right eye, the left eye is being reported as a malfunction under mfr's report # 1061857-2008-00092. Pt records were received and do not indicate an injury for the right eye. Ucva improved from 20/150 to 20/20-2. No other visual difficulties were noted in the pt's records. The surgeon stated there was no pt harm/injury associated with this event.

 
Manufacturer Narrative

Reporting of this complaint at this time is based on a previously filed serious injury mdr for complaint. As a result of that injury report, a 2-yr reporting timeframe was initiated for tall complaints of the same type. All complaint files for the ladarvision4000 were reviewed for this type of event starting 2007. This mdr filing is a result of that retrospective review. A surgery database performance verification was conducted on this sys and the analysis indicated the laser performance factors analyzed were operating within specification during the time of this pt's surgery. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary when add'l reportable info becomes available. This report mailed in to fda on: 06/06/2008.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CTR.
2501 discovery dr.
ste. 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CTR
2501 discovery dr.
ste. 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1058103
Report Number1061857-2008-00091
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/03/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065030501
OTHER Device ID Number5.5.0.
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/03/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2001
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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