BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 12905444 · Received November 30, 2021

    Report

    Report Number
    1211998-2021-00065
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    September 19, 2019
    Report Date
    November 22, 2021
    Manufacturer
    BEAVER VISITEC INTERNATIONAL INC.
    Product Code
    HMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BVI COMPLETED A SEARCH OF THE COMPLAINT DATABASE WHICH DID NOT REVEAL ANY COMPLAINTS ASSOCIATED WITH THIS ALLEGED ADVERSE EVENT PRIOR TO BEING NOTIFIED ON 11/08/2021.

    Description of Event or Problem · 0

    BVI RECEIVED A NOTICE OF THE FOLLOWING EVENT ALLEGEDLY RESULTING FROM THE SEPARATION OF THE AC CANNULA FROM THE SYRINGE DURING SURGERY: "RIGHT EYE INJURED DURING CATARACT SURGERY RESULTING IN DISPLACED PROSTHETIC LENS AND TORN RETINA (IN TWO PLACES) IN RIGHT EYE REQUIRING EMERGENCY SURGERY THE NEXT DAY" AND "PERMANENT LOSS OF VISION IN RIGHT EYE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802001 UNKNOWN ANTERIOR CHAMBER CANNULA HMX BEAVER VISITEC INTERNATIONAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other