BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 23013767 · Received September 10, 2025

    Report

    Report Number
    1119421-2025-02434
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 14, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389303
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (TFNT30-60) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P040020). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE LENS WAS RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. THE LENS IS ADHERED TO THE BOTTOM OF THE LENS CASE LID. A SMALL PIECE OF LENS MATERIAL IS LOOSE ON THE OUTER LIP OF THE LENS CASE LID. ONE HAPTIC IS FOLDED AND ADHERED TO THE EDGE OF THE OPTIC BY SOLUTION. THE OPPOSITE HAPTIC IS BROKEN ON THE DISTAL TIP. THE OPTIC IS SPLIT IN THE GUSSET AREA OF THE BROKEN HAPTIC. A SMALL CRACK IS OBSERVED ON THE OPTIC NEAR THE AREA THAT IS SPLIT. THE RETURNED LENS MATCHES THE PROVIDED PHOTO(S). A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. BROKEN HAPTIC DAMAGE WAS OBSERVED. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET COMPANY RELEASE CRITERIA. BASED ON OUR OBSERVATION, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE IFU INSTRUCTS: USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE HEALTH CARE PROFESSIONAL STATED THAT HAPTIC WAS DAMAGED BEFORE IMPLANTATION. THE SURGERY WAS COMPLETED BY USING BACKUP LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062812 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15409068 00380652389303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH III IOL, CARTRIDGE D.| MONARCH III IOL, INJECTOR.| UNSPECIFIED BACKUP LENS.| VISCOAT.