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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 05/22/2008
Event Type  Injury  
Event Description

A surgeon reports a pt that is overcorrected in both eyes following bilateral myopia with astigmatism refractive surgery. This report is for the right eye, the left eye is being reported under mfr report #1061857-2008-00149. At two weeks post-op, the left eye is overcorrected by +. 75 diopter and bcva is 20/20 (equal to pre-op). Additional info has been requested.

 
Manufacturer Narrative

A surgery database performance verification was performed on this system. The analysis determined the laser performance factors analyzed were operating within spec during the time of this pt's surgery. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional 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 dr ste 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr ste 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1077455
Report Number1061857-2008-00148
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2008
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 Received06/13/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/11/2002
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: 07/11/2008 Patient Sequence Number: 1
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