BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2020534 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00118
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: A COMPANY REP EXAMINED THE SYS AND WAS ABLE TO CONFIRM THE REPORTED SYS MESSAGE. THE FOOTSWITCH AND CABLE WERE FIRST REPLACED AND THE SYS MESSAGE REMAINED. THE FOOTSWITCH INTERFACE PRINTED CIRCUIT BOARD (PCB) WAS THEN REPLACED, AND THE ISSUE WAS RESOLVED. UNRELATED TO THE COMPLAINT, THE FMS EJECT BUTTON WAS ALSO REPLACED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. ACTIONS TAKEN: NO ADDITIONAL ACTION IS PLANNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE NURSE MANAGER REPORTED THAT THE FOOTSWITCH WAS NOT WORKING DURING SYS SET UP. AN ERROR CODE DISPLAYED AND THE SYS WAS BLOCKED. THE SURGEON HAD ALREADY STARTED THE PROCEDURE WHEN THE EVENT OCCURRED. THE PT WAS UNDER LOCAL ANESTHESIA, AN INCISION WAS MADE AND THE CAPSULORHEXIS HAD BEEN COMPLETED. ANOTHER FOOTSWITCH WAS CONNECTED TO THE SYS AND THE SYS WOULD NOT RESPOND AS WELL. THE SECOND FOOTSWITCH WAS THEN TRIED ON ANOTHER SYS AND AN ERROR CODE DISPLAYED AND THE SYSTEM COULD NOT BE USED EITHER. THE PROCEDURE WAS COMPLETED THREE HOURS LATER WITH ONE OF THE SYSTEMS, AFTER IT WAS REPAIRED BY THE TECHNICIAN. THE PT HAD BEEN GIVEN A PROPHYLACTIC ANTIBIOTIC TREATMENT. NO PT INJURY WAS REPORTED POSTOPERATIVELY. NO PT HARM WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.

    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