BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 19674911 · Received July 4, 2024

    Report

    Report Number
    1119421-2024-01256
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    May 31, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389389
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    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). ADDITIONAL INFORMATION HAS BEEN 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. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT HAS NOT BEEN RECEIVED TO EVALUATE. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE IFU INSTRUCTS: COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH A COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE IFU INSTRUCTS THAT A 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 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. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUESTS FOR FOLLOW-UP INFORMATION. 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 NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT A SCRATCH ON THE LENS, REPLACED USING THE BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182473 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15636818 00380652389389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PACKER CHANG IOL CUTTER