BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2000357 · Received February 18, 2011

    Report

    Report Number
    2028159-2011-00148
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN SAMPLE FOR EVALUATION. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED AND THIS IS THE FIRST REPORTED ISSUE FOR THIS FACILITY. THE FINISHED GOOD LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A CATARACT EXTRACTION PROCEDURE WITH AN INTRAOCULAR LENS IMPLANT (IOL), THE SYSTEM TURNED OFF. THE SYSTEM WAS REBOOTED WITH A NEW CASSETTE, BUT AN ERROR MESSAGE DISPLAYED AND THE SYSTEM LOCKED. THE PROCEDURE WAS CONVERTED TO AN EXTRACAPSULAR EXTRACTION WITH IOL AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO INJURIES TO THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED ONE HOUR.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention