BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYA IS INJECTOR SYSTEM

    MDR report key: 1993635 · Received January 6, 2011

    Report

    Report Number
    3006723646-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 6, 2011
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    MSS
    PMA / PMN Number
    K081346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CARTRIDGE CRACKED DURING LENS INSERTION. LENS WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYA IS INJECTOR SYSTEM MSS HOYA SURGICAL OPTICS, INC. E1 E110027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention