BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 7156355 · Received December 31, 2017

    Report

    Report Number
    1119421-2017-01492
    Event Type
    Malfunction
    Date Received
    December 31, 2017
    Date of Event
    December 5, 2017
    Report Date
    February 19, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MSS
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2017-103223.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED BLACK FILM SUBSTANCE INSIDE OF A CARTRIDGE DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. NO KNOWN ISSUES WERE OBSERVED WITH THE PATIENT.

    Description of Event or Problem · 1

    SUBSEQUENT FOLLOW UP FROM THE MD INDICATES, ¿IT TURNS OUT THAT THE CASE REFERENCED BELOW WAS NOT AN ISSUE WITH FOREIGN MATERIAL ON THE LENS. THERE WERE SMALL SCRATCHES ON THE EDGE OF THE LENS, WHICH IS OF NO CONSEQUENCE TO THE PATIENT OR SURGEON AND USUALLY RELATED TO MECHANICAL DAMAGE WHEN IT IS LOADED OR UNLOADED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935342 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LTD. - HUNTINGTON NA 32575028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other