BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 14773414 · Received June 22, 2022

    Report

    Report Number
    1119421-2022-01352
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    April 19, 2022
    Report Date
    July 21, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    (EVAL CODE UPDATED TO 4101 FROM 10). THE USED CARTRIDGE WAS NOT RETURNED. SIX OPENED, LOOSE CARTRIDGES WERE RETURNED. THE RETURNED, LOOSE CARTRIDGES WERE NUMBERED 1-6 FOR EVALUATION PURPOSES. ALL SIX CARTRIDGES WERE MICROSCOPICALLY EXAMINED. NO APPARENT VISCOELASTIC WAS OBSERVED. NO CARTRIDGE DAMAGE WAS OBSERVED. NO PARTICULATE WAS OBSERVED INSIDE THE CARTRIDGES. NONE OF THE SIX LOOSE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO AN COMPANY HANDPIECE. THE SIX CARTRIDGE WERE CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A NON-COMPANY LENS WAS INDICATED. THE HANDPIECE AND VISCOELASTIC USED WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE USED COMPANY CARTRIDGE COMPLAINT SAMPLES WERE NOT RETURNED. NO DETERMINATION CAN BE MADE WITHOUT PHYSICAL EVALUATION OF THE COMPLAINT SAMPLE. THE SIX LOOSE CARTRIDGES WERE EVALUATED. NO DAMAGE OR FOREIGN MATERIAL WAS OBSERVED. DYE STAIN TESTING WAS CONDUCTED WITH THE LOOSE SAMPLES WITH ACCEPTABLE RESULTS. A NON-COMPANY LENS WAS INDICATED. THE HANDPIECE AND VISCOELASTIC USED WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. PER THE INSTRUCTIONS FOR USE (IFU): THE COMPANY IOL DELIVERY SYSTEM IS FOR IMPLANTATION OF QUALIFIED COMPANY FOLDABLE IOLS. NO UNQUALIFIED LENSES SHOULD BE USED WITH THE COMPANY IOL DELIVERY SYSTEM. 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 ALSO 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 ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE COATING OF THE INSIDE OF THE CARTRIDGE WAS ADHERED TO THE IOL WHEN USING WHICH WAS FOUND AFTER IMPLANTATION. IT WAS REMOVED FROM THE EYE BY IRRIGATION AND ASPIRATION. THERE WAS NO PROBLEM. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599251 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA 15302632 00380659777639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NON COMPANY IOL