BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1033538 · Received April 24, 2008

    Report

    Report Number
    2028159-2008-00143
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE ERROR MESSAGE. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECS. THE SURGEON CONFIRMED THE COMPANY SERVICE REP DID NOT FIND ANYTHING WRONG WITH THE SYSTEM. THE SYSTEM HAS BEEN FUNCTIONING PROPERLY SINCE THEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON THE FIRST CASE OF THE DAY AN OCCLUSION OCCURRED DURING THIRD QUADRANT REMOVAL OF THE CATARACT. THE NUCLEUS WAS VERY DENSE AND HARD. THE OCCLUSION BELL KEPT GOING OFF DURING IRRIGATION AND ASPIRATION FOR THE REMAINDER OF THE CASE. THE TIP WAS REMOVED AND PLACED IN A CUP OF BSS TO CLEAR THE OCCLUSION. THE OCCLUSION DID NOT CLEAR. THE CUSTOMER SWITCHED OUT THE TUBING, HANDPIECE, AND SYSTEM; BUT STILL KEPT GETTING THE OCCLUSION ERROR MESSAGE. THE CASE WAS FINISHED WITH THE IOL IMPLANTED WITH NO PROBLEMS. THE SURGEON CANCELLED THE REST OF THE CASES FOR THE DAY (FIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OPHTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI DUOVISC