BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4223655 · Received October 31, 2014

    Report

    Report Number
    2028159-2014-02026
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE PATIENT EXPERIENCED A POSTERIOR CAPSULE TEAR DURING A CATARACT SURGERY. THE SURGEON THOUGHT THAT THE TEAR MAY HAVE OCCURRED DUE TO POSITIONING OF THE PATIENT'S HEAD CREATING DIFFICULTY WITH THE VIEW. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698052 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other