BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH IOL DELIVERY SYSTEM HANDPIECE - UNK

    MDR report key: 3771016 · Received December 18, 2013

    Report

    Report Number
    2523835-2013-00191
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 29, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINGKING SPRING
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RECEIVED, NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFO WAS PROVIDED FOR A LOT RECORD REVIEW, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE COMPLAINT INFO DOES INDICATE THE CUSTOMER DID NOT USE THE CORRECT CARTRIDGE. (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. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663937 MONARCH IOL DELIVERY SYSTEM HANDPIECE - UNK LENS GUIDE HQL ALCON PRECISION DEVICE - SINGKING SPRING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MN60AC, MP (SN. 12202794053)| MONARCH IOL DELIVERY SYSTEM CARTRIDGE