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Adverse Event Report

ALCON - ORLANDO TECHNOLOGY CTR LADAR6000 OPHTHALMIC EXCIMER LASER SYSTEM   back to search results
Catalog Number 8065990007
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/29/2006
Event Type  Malfunction  
Event Description

A system operator reports one custom pt with topographically-observed "central islands" (corneal irregularities) following a bilateral custom myopia laser procedure. There was no injury/impact associated with this event. This report is being submitted for the left eye, the right eye is being submitted under mfr report number 1061857-2007-00084. Surface irregularities associated with laser refractive surgery can interfere with vision. Some irregularities spontaneously resolve after several months. Patients with persisting irregularities may be treated with alternative methods including spectacle correction, contact lens correction or surgery.

 
Manufacturer Narrative

Investigation including root cause determination is in progress.

 
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Brand NameLADAR6000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Baseline Brand NameLADAR6000
Baseline Generic NameOPHTHALMIC EXCIMER LASER SYSTEM
Baseline Catalogue Number8065990007
Other Baseline ID Number6.4.0
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALCON - ORLANDO TECHNOLOGY CTR
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CTR
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer Contact
sherri lakota
2501 discovery drive
suite 500
orlando , FL 32826
(407) 384 -1644
Device Event Key815492
MDR Report Key828086
Event Key791208
Report Number1061857-2007-00085
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/14/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/2007
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
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2007
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
Removal/Correction Number1061857-02/21/2007-002-C

Database last updated on February 28, 2009

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