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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 8065040601
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/08/2007
Event Type  Injury  
Event Description

A surgeon reports a patient with decreased bcva following an enhancement procedure. The initial procedure was performed on a different model laser/ manufacturer report #1061857-2007-00420 was submitted for the patient's outcome prior to the enhancement procedure. This report is for the patient's outcome following the enhancement procedure. The day of the enhancement, just prior to the procedure, bcva in the right eye was 20/15. One month post-enhancement, bcva in the right eye was 20/20.

 
Manufacturer Narrative

There have been no other similar complaints reported for this device following receipt of this complaint. 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.

 
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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 (Section G)
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 Key1055610
Report Number1061857-2008-00102
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/03/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065040601
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/03/2007
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/17/2001
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: 06/03/2008 Patient Sequence Number: 1
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