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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALOCN - ORLANOD TECHNOLOGY CENTER APEX PLUS OPHTHALMIC EXCIMER LASER SYSTEM

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ALOCN - ORLANOD TECHNOLOGY CENTER APEX PLUS OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/1999
Event Type  Injury  
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Brand NameAPEX PLUS
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALOCN - ORLANOD TECHNOLOGY CENTER
2501 discovery drive.
ste 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 Key1066087
Report Number1061857-2008-00103
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/13/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2008
Date Manufacturer Received05/13/2008
Was Device Evaluated By Manufacturer? No
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: 06/12/2008 Patient Sequence Number: 1
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