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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 8065990008
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/06/2006
Event Type  Malfunction  
Event Description

A surgeon reports a patient with central islands following bilateral myopia with astigmatism refractive surgery. An enhancement procedure (laser platform unknown) was performed approximately five and a half months following the initial procedure to address a small amount of residual astigmatism. The patient did report some blurriness in the left eye since the enhancement procedure. The surgeon plans to review the patient's status in approximately 5 months. Additional information has been requested. This report is for the left eye, the right eye is being reported under manufacturer report #1061857-2008-00156.

 
Manufacturer Narrative

Determination of root cause: assessment: a surgery database performance verification was conducted on this system. The analysis determined the laser performance factors analyzed were operating within specification during the time of this patient's surgery. Preliminary review of the patient's pre-op and post-op topographies could not definitively identify characteristics of central islands. Additional topographies along with patient records have been requested. A supplemental mdr will be filed as necessary when additional reportable information becomes available. Conclusion: despite extensive investigation, the root cause for the occurrence of central islands has not be determined. This report mailed in to fda on: 07/17/2008.

 
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Brand NameLADAR6000
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 dr
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1079285
Report Number1061857-2008-00157
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990008
OTHER Device ID Number6.4.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/17/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number1061857-02/21/2007-002-C

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