BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, INJECTOR

    MDR report key: 16045784 · Received December 24, 2022

    Report

    Report Number
    2523835-2022-00484
    Event Type
    Malfunction
    Date Received
    December 24, 2022
    Date of Event
    November 10, 2022
    Report Date
    March 21, 2023
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    KYB
    UDI-DI
    00380659777738
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF POSTERIOR LOOP OF LENS CLAMPED OFF DUE TO DEFECT OF INJECTOR; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM THE CHINA HA STATING THE DISTAL END OF THE POSTERIOR LOOP OF THE INTRAOCULAR LENS WAS CLAMPED OFF DUE TO THE DEFECT OF THE LENS INJECTOR. ON THE FIRST DAY AFTER OPERATION, THE PATIENT HAD CENTRAL CORNEAL EDEMA, ENDOTHELIAL FOLDS, NAKED EYE VISUAL ACUITY OF 0.2, AND INTRAOCULAR PRESSURE OF 17.9 MMHG. THE PATIENT WAS DISCHARGED WITHOUT COMPLAINT OF SPECIAL DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739943 MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - ALCON PRECISION DEVICE III ASKU 00380659777738

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male