BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC PLUS VISCOELASTIC

    MDR report key: 3908467 · Received June 12, 2014

    Report

    Report Number
    1119279-2014-00129
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ON PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA DETACHED AND BROKE THE PATIENT'S CAPSULE. A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS LEFT APHAKIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348174 AMVISC PLUS VISCOELASTIC SURGICAL VISCOELASTIC MATERIAL LZP LIFECORE BIOMEDICAL, LLC 60081L 025097

    Patients

    Seq Age Sex Outcome Treatment
    1 Other