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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 8065490006
Device Problem Tracking
Event Date 05/01/2008
Event Type  Malfunction  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when add'l reportable info becomes available.

 
Event Description

A sys operator reports loss of tracking during surgery. There was no pt impact/injury associated with this event.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
ste 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
ste 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1056527
Report Number1061857-2008-00083
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2008
Is This An Adverse Event Report? No
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
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/01/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/24/2000
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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