BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON TORIC IOL

    MDR report key: 19391156 · Received May 24, 2024

    Report

    Report Number
    1119421-2024-01005
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 23, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652402309
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. IT IS UNKNOWN IF ADEQUATE VISCOELASTIC WAS USED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD 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 IFU INSTRUCTS: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL TO STAY IN THE FOLDED CONDITION. FAILURE TO ADHERE TO MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL DAMAGE. IFU NOTE: DURING LENS LOADING AND INSERTION, DO NOT ALLOW THE COMPANY IOL TO REMAIN IN A FOLDED CONDITION WITHIN THE SELECTED IOL DELIVERY SYSTEM FOR MORE THAN 3 MINUTES PRIOR TO COMPLETING INSERTION INTO THE CAPSULAR BAG. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS LOADED IN THE CARTRIDGE SMOOTHLY WITHOUT ISSUE. THE SURGEON IMPLANTED THE LENS WAS NOTICED TEAR IN THE OPTIC AND THE EDGES HAD WHITISH BRITTLE CRACKING. THE LENS WAS CUT AND REMOVED AND NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND UPDATED VIA MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299203 CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CNW0T3 15654627 00380652402309

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male MONARCH II LOADING FORCEPS| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE