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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 06/08/2007
Event Type  Injury  
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 pt's surgery. Preliminary review of the pt's pre-op and post-op topographies could not definitively identify characteristics of central islands. Add'l topographies along with pt records have been requested. A supplemental mdr will filed as necessary in accordance with 21 cfr 803. 56 when add'l reportable info becomes available. Conclusion: despite extensive investigation, the root cause for the occurrence of central islands has not been determined.

 
Event Description

A surgeon reports a pt with central islands following bilateral refractive surgery. An enhancement treatment (laser platform unk) was performed 5. 25 months following the inital procedure to address residual astigmatism. This report is for the right eye, the left eye is being reported under manufacturer report # 1061857-2008-00162. The latest info provided indicates the pt has experienced a 1-line decrease in bcva in the right eye from the pre-op measurement. The surgeon plans to review the pt's status in approximately 5 months. Add'l info has been requested.

 
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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 drive
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1080885
Report Number1061857-2008-00161
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
1 Patient Was Involved in the Event
Date FDA Received07/17/2008
Is This An Adverse Event Report? Yes
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

Patient TREATMENT DATA
Date Received: 07/17/2008 Patient Sequence Number: 1
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