BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2801106 · Received October 17, 2012

    Report

    Report Number
    2028159-2012-01599
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    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
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SERVICE REPORT INDICATES THAT THE CUSTOMER REPORTED "SURGE OCCURRED DURING SURGERY". PER THE SERVICE REQUESTED, THE COMPANY REP WAS ABLE TO RESOLVE THE REPORTED EVENT REMOTELY WITH THE CUSTOMER AND CONFIRMED THE SYSTEM WAS CONFORMING. THE CUSTOMER SWITCHED OUT THE CASSETTE AND COMPLETED THE CASE AS PLANNED. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 2 SIMILAR REPORT(S) FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO A NON-CONFORMING CASSETTE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A "SURGE" DURING A CATARACT EXTRACTION PROCEDURE. THE CASSETTE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1