BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 14317382 · Received May 7, 2022

    Report

    Report Number
    1119421-2022-00962
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 10, 2022
    Report Date
    June 27, 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 NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE USED COMPLAINT COMPANY CARTRIDGE WAS NOT RETURNED. SIX UNOPENED COMPANY CARTRIDGES WERE RETURNED IN AN OPENED 10-COUNT CARTON. ONE UNOPENED COMPANY CARTRIDGE WAS PULLED RANDOMLY FROM THE CARTON. THE RETURNED UNUSED COMPANY CARTRIDGE WAS EVALUATED. THE COMPANY CARTRIDGE WAS OPENED AND MICROSCOPICALLY EXAMINED WITH NO DAMAGE OBSERVED. NO PARTICULATE WAS OBSERVED INSIDE THE CARTRIDGE LUMEN. THE COMPANY CARTRIDGE WAS FUNCTIONALLY TESTED PER THE IFU(INSTRUCTIONS FOR USE). NO LENS OR CARTRIDGE DAMAGE WAS OBSERVED AFTER THE LENS DELIVERY. NO FOREIGN MATERIAL WAS OBSERVED. THE COMPANY CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. A COMPANY HANDPIECE AND A NON-COMPANY LENS WERE INDICATED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE USED COMPANY CARTRIDGE COMPLAINT SAMPLE WAS NOT RETURNED. NO DETERMINATION CAN BE MADE WITHOUT PHYSICAL EVALUATION OF THE COMPLAINT SAMPLE. ONE OF THE UNOPENED COMPANY CARTRIDGES RETURNED FOR THE REPORTED LOT WAS EVALUATED. NO FOREIGN MATERIAL WAS OBSERVED. FUNCTIONAL AND DYE STAIN TESTING WAS CONDUCTED WITH THE UNOPENED SAMPLE WITH ACCEPTABLE RESULTS. NO FOREIGN MATERIAL WAS OBSERVED AFTER THE FUNCTIONAL TESTING. A NON-COMPANY LENS WAS INDICATED. PER THE IFU: THE COMPANY 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. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. PER THE HANDPIECE IFU: THE QUALIFIED CARTRIDGE/IOL COMBINATIONS HAVE BEEN VALIDATED AT AN AMBIENT TEMPERATURE OF 18 °C USING THE DRIVING CONSOLE SETTING (1.7 MM/SEC, 3 SECONDS, AND 3.0 MM/SEC FOR INITIAL VELOCITY, PAUSE AND FINAL VELOCITY RESPECTIVELY). USING A HIGHER VELOCITY AND SHORTER PAUSE AT LOWER TEMPERATURES, ESPECIALLY WITH HIGH DIOPTER LENSES, COULD INDUCE DAMAGE TO IOL AND/OR IOL CARTRIDGE, AFFECTING SUCCESSFUL IOL IMPLANTATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE INSIDE OF THE CARTRIDGE LOOKED LIKE IT HAD BEEN SCRAPED, AND A FOREIGN MATERIALS LIKE SOME PLASTIC SHAVINGS CAME OUT. THE FOREIGN MATERIALS WERE ASPIRATED AND REMOVED WITH IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE CARTRIDGE WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253171 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA 15302880 00380659777639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AMO PCB| INTREPID AUTOSERT