BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2020539 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00100
    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

    THE COMPANY REP EXAMINED THE FOOTSWITCH AND REPLACED THE FOOTSWITCH INTERFACE PRINTED CIRCUIT BOARD (PCB) AND FOOTSWITCH CABLE. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT THE FOOTSWITCH WOULD NOT WORK DURING THE SET UP OF THE SYS. AN ERROR CODE WAS DISPLAYED AND THE SYS WAS LOCKED. THE SURGEON HAD ALREADY STARTED THE PROCEDURE AND WAS DOING THE CAPSULORHEXIS WHEN THE EVENT OCCURRED. ANOTHER SECOND FOOTSWITCH WAS CONNECTED BUT THE SYS WAS STILL LOCKED. THE FOOTSWITCH WAS TRIED ON A SECOND SYS AND AN ERROR CODE APPEARED. THE SURGERY WAS COMPLETED THREE HOURS LATER AFTER THE SYS WAS REPAIRED BY A TECHNICIAN. THE PT WAS GIVEN A PROPHYLACTIC ANTIBIOTIC TREATMENT. NO PT INJURY WAS REPORTED. THE FOLLOWING FIVE PROCEDURES OF THE DAY WERE CANCELED. 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