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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 8065490084
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/10/2008
Event Type  Injury  
Manufacturer Narrative

A surgery database performance verification was conducted on this system. The analysis determined that the laser performance factors analyzed were operating within specification during the time of this patient's enhancement surgery.

 
Event Description

A surgeon originally reported a patient with topographically-observed "central islands" (corneal irregularities) following a custom myopia with astigmatism laser procedure. The patient's outcome following the initial procedure was reported under mfr report #1061857-2007-00332. An enhancement procedure was performed on a different laser platform from the initial procedure. This report is for the pt's outcome following that enhancement procedure. At approx 2 months post-enhancement, the pt's bcva is 20/80, a 4 line decrease from pre-enhancement and ucva is 20/400. Notes on the pt's records indicate, "right cornea has +1/2 reticular haze centrally with pericentral tough supero-temporally".

 
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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 Key1081320
Report Number1061857-2008-00163
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065490084
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/24/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/26/2002
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: 07/24/2008 Patient Sequence Number: 1
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