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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 8065490006
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/20/2005
Event Type  Injury  
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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.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1066092
Report Number1061857-2008-00117
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer,Health Professional
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065490006
OTHER Device ID NumberJ4, CSPS, M3
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2008
Date Manufacturer Received05/20/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2001
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: 06/19/2008 Patient Sequence Number: 1
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