BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - UNK

    MDR report key: 3771038 · Received December 18, 2013

    Report

    Report Number
    2523835-2013-00195
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 29, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4. )

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR FOLDED THE HAPTIC, CAUSING A DEFORMATION, AND THE IOL FELL INTO THE VITREOUS. THE SURGEON REMOVED AND REPLACED THE IOL DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664387 MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - UNK LENS GUIDE HQL ALCON PRECISION DEVICE - SINKING SPRING NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MN60AC, MP (SN. (B)(4))| MONARCH IOL DELIVERY SYSTEM HANDPIECE - UNK