BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1740208 · Received June 25, 2010

    Report

    Report Number
    2028159-2010-00992
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECS. THE COMPANY SERVICE REP REPORTED THE DR WHO REPORTED THE INCIDENT HAS A VERY LARGE SIZED FOOT AND WHEN HE DEPRESSED THE FOOT PEDAL TO ACTIVATE THE PHACOEMULSIFICATION FUNCTIONS, HE INADVERTENTLY HIT THE LEFT LATERAL BUTTON ACTIVATING THE REFLUX FEATURE AT THE SAME TIME. WHEN THE BUTTON SETTINGS WERE EXAMINED, THE LEFT TOP BUTTON OF THE FOOTSWITCH DID DEFAULT TO REFLUX ACTIVATION. THE SITE WAS ADVISED TO ADJUST THE FOOTSWITCH BUTTONS TO ACCOMMODATE VARIOUS DR'S FOOT SIZES AS NEEDED. QA WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT IMPACT" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "UNWARRANTED REFLUX" (REFLUX WITHIN DEVICE); "DECREASED FLOW" (INSUFFICIENT FLOW OR UNDERINFUSION); "DID NOT GET AS MUCH ASPIRATION AS EXPECTED" (ASPIRATION ISSUE). THE CUSTOMER REPORTED WHILE IN SCULPT MODE, THE SURGEON ONLY GOT ABOUT 3/4 OF THE PHACOEMULSIFICATION POWER THAT HE WAS EXPECTING. ALSO, REFLUX WAS BEING ACTIVATED WHEN THE DR WAS NOT REQUESTING REFLUX AND THERE WAS A DECREASED FLOW. THE CASSETTE, BOTTLE, AND HANDPIECE TIP WAS REPLACED AND THE SET-UP WAS RE-DONE. THE IRRIGATION/ASPIRATION HANDPIECE WAS USED TO FINISH THE CASE ALTHOUGH THE SURGEON DID NOT GET AS MUCH ASPIRATION AS HE HAD EXPECTED. THE SYSTEM WAS SWITCHED OUT TO A DIFFERENT SYSTEM TO COMPLETE SUBSEQUENT CASES. THERE WAS NO PT IMPACT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1