BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC VISCOELASTIC

    MDR report key: 3890638 · Received May 30, 2014

    Report

    Report Number
    1119279-2014-00118
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT DURING LENS INSERTION THE CAPSULAR BAG WAS DAMAGED. THE LENS WAS REMOVED AND A VITRECTOMY WAS PERFORMED. A DIFFERENT MODEL LENS WAS IMPLANTED. THE DOCTOR BELIEVES THE PT WILL ULTIMATELY DO WELL. THE INSERTER USED IN THIS EVENT WAS NOT A B+L INSERTER. THE LENS THAT WAS USED DURING THIS EVENT IS REPORTED UNDER 1119279-2014-00117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319893 AMVISC VISCOELASTIC SURGICAL VISCOELASTIC MATERIAL LZP LIFECORE BIOMEDICAL, LLC 59081L

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SOFPORT INTRAOCULAR LENS