BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, INJECTOR

    MDR report key: 19151222 · Received April 22, 2024

    Report

    Report Number
    2523835-2024-00695
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    KYB
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR IOL (INTRA OCULAR LENS) DELIVERY, LOT UNK - INJECTOR OVERRODE THE LENS (IN AND OUT); 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. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION WAS PROVIDED; THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE AND OBSERVED THAT THERE WAS A CRACK ON LENS. THE LENS WAS EXPLANTED IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED, DIFFERENT PERSON LOADED THE SECOND LENS FOR THE DOCTOR THE ORIGINAL PERSON THAT LOADED THE DAMAGED LENS BELIEVES SHE DID NOT PUSH THE LENS ALL THE WAY FORWARD IN THE CARTRIDGE. THE DOCTOR SAID THE INJECTOR OVERRODE THE LENS AT FIRST. THE SECOND LENS LOADED BY A DIFFERENT TECHNICIAN WAS LOADED PROPERLY AND IMPLANTED WITHOUT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254663 MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - ALCON PRECISION DEVICE III ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female AMVISC VISCOELASTIC| CLAREON PANOPTIX LENS| MONARCH III CARTRIDGE D