BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

    MDR report key: 19268167 · Received May 8, 2024

    Report

    Report Number
    1119421-2024-00880
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652413640
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. PHOTO WAS PROVIDED OF A SINGLE-PIECE MULTI-FOCAL LENS IN THE EYE. A MARK, WHICH APPEARS TO BE A SMALL SCRAPE, WAS OBSERVED NEAR THE EDGE OF THE OPTIC ON THE ANTERIOR SURFACE. A DETERMINATION FOR THE CAUSE OF THE DAMAGE CANNOT BE MADE FROM THE PHOTO. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF QUALIFIED ASSOCIATED PRODUCTS. BASED ON OUR OBSERVATION OF THE ATTACHED PHOTO, A MARK, WHICH APPEARS TO BE A SMALL SCRAPE, WAS OBSERVED NEAR THE EDGE OF THE OPTIC ON THE ANTERIOR SURFACE. IF THE LENS IS LOADED PER THE INSTRUCTIONS FOR USE (IFU), THE ANTERIOR SURFACE DOES NOT CONTACT THE INNER LUMEN OF THE CARTRIDGE. IT IS DIFFICULT TO MAKE A FINAL DETERMINATION WITHOUT EVALUATION OF THE PHYSICAL SAMPLE. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICE (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 INTRAOCULAR LENS (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. IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT COMPANY. THE HANDPIECE IFU INSTRUCTS: VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY 1/2 TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED WITH A DESCRIPTION OF SMALL SCRATCH ON POSTERIOR PART OF INTRAOCULAR LENS (IOL). THEY FOLLOWED ALL THE USUAL INSTRUCTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140379 CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON CCWTT0 15652567 00380652413640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON MONARCH IV INJECTOR| DUOVISC| MONARCH III CARTRIDGE D| UNSPECIFIED LOADING FORCEPS