BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 20760368 · Received November 22, 2024

    Report

    Report Number
    1119421-2024-02297
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 25, 2024
    Report Date
    February 10, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389532
    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). 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

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11. THE LENS WAS NOT RETURNED IN THE REPORTED CONDITION OF STUCK. THE LENS WAS REPLACED INTO THE LENS CASE INSIDE THE LENS CARTON. VISCOELASTIC AND WHAT APPEARED TO POSSIBLY BE A SMALL AMOUNT OF BLOOD ON THE DISTAL HAPTIC TIP WAS OBSERVED. THIS HAPTIC WAS BENT IN THE GUSSET AND DISTAL AREA. THE OTHER HAPTIC WAS BROKEN FROM THE OPTIC INCLUDING A LARGE PORTION OF OPTIC MATERIAL. THE POSTERIOR OPTIC SURFACE HAS CRACKED DAMAGE NEAR THE EDGE IN TWO SEPARATE AREAS. THE ANTERIOR OPTIC SURFACE WAS SCRATCHED IN THE OPTIC CENTER. TWO AREAS OF CRACKED DAMAGE AND TWO SCRAPE MARKS WERE OBSERVED ON THE ANTERIOR OPTIC SURFACE NEAR THE BROKEN OPTIC DAMAGE. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ASSOCIATED CARTRIDGE, HANDPIECE, AND VISCOELASTIC INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE REPORTED BROKEN HAPTIC DAMAGE WAS OBSERVED. ALL LENSES ARE 100 PERCENT 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, POTENTIAL BLOOD, AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THE INSTRUCTIONS FOR USE (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 OPHTHALMIC VISCOSURGICAL DEVICE (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. IT CANNOT BE CONFIRMED IF THE LENS HAD BECOME STUCK DURING THE DELIVERY. THE ASSOCIATED CARTRIDGE WAS NOT RETURNED FOR AN EVALUATION. IT IS UNKNOWN IF QUALIFIED ASSOCIATED 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. 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 IS RECEIVED. 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).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS STUCK INSIDE THE TUNNEL, HAPTIC BROKE OFF AFTER THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798947 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15695068 00380652389532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown