BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3192936 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01132
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND THE REPORTED EVENT WAS REPLICATED. THE SYSTEM GENERATED SYSTEM MESSAGE (SM) - ENCODER FAILURE AND SM - DETENT FAILURE. THE FOOTSWITCH PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION 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 NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE, THE FOOTSWITCH WOULD NOT RESPOND. THE PATIENT WAS TRANSFERRED BY AMBULANCE TO ANOTHER FACILITY TO HAVE THE SURGERY COMPLETED. THERE WAS A SIGNIFICANT DELAY AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287097 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention