BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 INSERTER SET

    MDR report key: 3152033 · Received December 4, 2009

    Report

    Report Number
    1920664-2009-00346
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 20, 2009
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2009-00331 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY SERVICE.

    Description of Event or Problem · 1

    THE LENS WAS DAMAGED DURING INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 INSERTER SET MSS BAUSCH & LOMB LP604350 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BAUSCH AND LOMB MI60LUS IOL