BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS

    MDR report key: 21606663 · Received March 14, 2025

    Report

    Report Number
    9612169-2025-00388
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Report Date
    May 30, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MFK
    UDI-DI
    00380652408202
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT 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. PHOTO REVIEW: PROVIDED PHOTO SHOWS AN IMPLANTED IOL. THERE APPEARS TO BE A DARK MARK/LINE AT THE GUSSET AREA OF THE HAPTIC. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D.10. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CUT NEAR THE TRAILING HAPTIC WAS OBSERVED. AS IOL WAS NOT INSPECTED PRE OPERATIVELY UNABLE TO SAY IF IT WAS THERE PRIOR TO LOADING. IOL LEFT IN THE EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NOTCH IN LENS NEAR HAPTIC JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399943 CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON LABORATORIES IRELAND LTD. CNWTT0 25424047 00380652408202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE