BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC

    MDR report key: 2800988 · Received October 18, 2012

    Report

    Report Number
    1119279-2012-00249
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN INJECTING AMVISC INTO THE PT'S EYE, THE CANNULA DETACHED FROM THE SYRINGE. THE DETACHED CANNULA HIT THE CATARACTOUS LENS AND BROKE OFF NINETY DEGREES OF ZONULES CAUSING THE LENS TO TILT PARTIALLY INTO THE BACK OF THE EYE. AN INCISION WAS MADE AND THE CANNULA WAS REMOVED. THE PT WAS REFERRED TO A VITREORETINAL SPECIALIST. THE SPECIALIST SUCCESSFULLY REMOVED THE CATARACT LENS AND IMPLANTED A NEW LENS. PT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVISC LZP, AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC 59081L 024022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other