BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 14141548 · Received April 19, 2022

    Report

    Report Number
    1119421-2022-00787
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 1, 2021
    Report Date
    June 8, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    UDI-DI
    00380659777639
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE USED COMPANY CARTRIDGE WAS NOT RETURNED. THREE VIDEOS AND TWO PHOTOS WERE PROVIDED IN A LINK. THE POWERPOINT PAGE INDICATED THREE PR NUMBERS. IT IS NOT CLEAR WHICH VIDEO CORRESPONDS TO EACH FILE. ALL THREE REVIEWS WILL BE PLACED IN THE INDICATED FILES. THE PROVIDED VIDEOS DID NOT SHOW THE LENS OR CARTRIDGE PREPARATION. TWO DELIVERIES WERE SHOWN AND ONE VIDEO WAS ONLY OF AN IMPLANTED LENS. ALL THREE LENSES HAD LINEAR MATERIAL OBSERVED ON THE POSTERIOR SURFACE OF THE OPTIC. THE MATERIAL WAS REMOVED AND THE LENSES REMAINED IMPLANTED. THE LENS MODEL/DIOPTER, HANDPIECE AND VISCOELASTIC RELATED TO THIS COMPLAINT WAS NOT PROVIDED. IT CANNOT BE DETERMINED IF A QUALIFIED COMBINATION WAS USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. BASED ON REVIEW OF THE PROVIDED VIDEOS, A LINEAR MATERIAL WAS OBSERVED ON THE POSTERIOR SURFACE OF THE OPTIC. THE MATERIAL WAS REMOVED WITH THE I/A TIP. THE LENSES REMAINED IMPLANTED. THE COMPANY CARTRIDGE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. NO DETERMINATION CAN BE MADE WITHOUT PHYSICAL EVALUATION OF THE COMPLAINT SAMPLE. IT IS UNKNOWN IF A QUALIFIED LENS MODEL/DIOPTER, HANDPIECE AND VISCOELASTIC WERE USED. PER THE INSTRUCTIONS FOR USE (IFU): THE COMPANY CARTRIDGES ARE QUALIFIED FOR USE WITH COMPATIBLE COMPANY HANDPIECES FOR THE SURGICAL IMPLANTATION OF COMPANY QUALIFIED FOLDABLE IOLS. COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD (DIAGRAM PROVIDED) IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION PLASTIC MATERIAL AND PLASTIC FIBER HAVE BEEN FOUND ON THE LENS. THE LENS WAS REMOVED FROM THE EYE IS THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE FIBERS ON THE POSTERIOR SURFACE OF THE LENS AFTER IMPLANTATION MIGHT HAVE COME FROM THE CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934969 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA ASKU 00380659777639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IOL, UNSPECIFIED