BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 21067682 · Received January 3, 2025

    Report

    Report Number
    1119421-2025-00053
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 9, 2024
    Report Date
    February 14, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389549
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. 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

    THE LENS WAS RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. BOTH HAPTICS ARE FOLDED OVER AND ADHERED TO THE OPTIC BY SOLUTION. MULTIPLE CRACKS ARE OBSERVED IN THE MIDDLE OF THE OPTIC PORTION OF THE LENS. MARKS ARE OBSERVED THE OPTIC THAT ARE SIMILAR TO THOSE LEFT BY A SURGICAL INSTRUMENT USED TO GRASP THE LENS. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. LENS 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. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. 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 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 REQUEST 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 NURSE REPORTED WITH THE DESCRIPTION OF INTRAOCULAR LENS (IOL) WITH CRACK IN THE MIDDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639354 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15711557 00380652389549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown