BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC

    MDR report key: 2504891 · Received March 23, 2012

    Report

    Report Number
    1119279-2012-00067
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 24, 2012
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY THEREFORE AN EVAL COULD NOT BE PERFORMED. THE LOT NUMBER OF THE DEVICE WAS NOT RECORDED BY THE USER FACILITY THEREFORE A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THIS EVENT IS PERFORMING WITHIN THE ANTICIPATED SEVERITY AND OCCURRENCE LEVELS AS DEFINED PER THE RISK ANALYSIS DOCUMENTATION. AN INVESTIGATION INTO THIS EVENT HAS BEEN OPENED TO EVALUATE POTENTIAL PRODUCT AND/OR INSTRUCTIONAL IMPROVEMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN INJECTING AMVISC INTO PT'S EYE THE CANNULA DETACHED FROM THE SYRINGE AND ADVANCED INTO THE PT'S EYE CAUSING THE IRIS TO BLEED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other