BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYA-IS INJECTOR SYSTEM

    MDR report key: 1898355 · Received October 28, 2010

    Report

    Report Number
    3006723646-2010-00119
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 27, 2010
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    MSS
    PMA / PMN Number
    K081346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC HAS RECEIVED CARTRIDGES FROM THE SAME LOT NUMBER AND WILL PERFORM AN INVESTIGATION. HOWEVER, WE BELIEVE IT IS UNLIKELY THAT A CARTRIDGE DEFECT CAUSED A TEAR IN THE CAPSULAR BAG BECAUSE A CARTRIDGE SHOULD HAVE NO CONTACT WITH THE CAPSULAR BAG IN ROUTINE CATARACT SURGERY.

    Description of Event or Problem · 1

    PATIENT CAPSULAR BAG TORE WHEN USING THE CARTRIDGE TO INSERT LENS, VITRECTOMY WAS PERFORMED. DOCTOR REPORTS THIS HAS HAPPENED THREE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYA-IS INJECTOR SYSTEM MSS HOYA SURGICAL OPTICS INC. E1 E11001L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention