BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 20260760 · Received September 19, 2024

    Report

    Report Number
    1119421-2024-01860
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    April 23, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389464
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN D.4. ADDITIONAL INFORMATION PROVIDED IN H.3. , H.6. AND H.11. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF A QUALIFIED ASSOCIATED CARTRIDGE AND HANDPIECE WITH A NON-QUALIFIED VISCOELASTIC. THE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE TO FOLLOW THE (INSTRUCTIONS FOR USE) IFU. THE VISCOELASTIC INDICATED IS NOT QUALIFIED FOR THE LENS/MONARCH COMBINATION USED. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE ACCOUNT INDICATED THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. FILE WILL BE REOPENED WHEN NEW INFORMATION IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED. THE SURGERY COMPLETED WITH REPLACEMENT LENS. THE LENS WAS EXCHANGED FOR SAME LENS MODEL DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329616 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15663697 00380652389464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR| SHPMC 2%