BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 22292689 · Received June 19, 2025

    Report

    Report Number
    1119421-2025-01704
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422901
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE 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 (DFT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10., H.3. AND H.11. THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. A ROOT CAUSE CANNOT BE DETERMINED WITHOUT PHYSICAL EXAMINATION OF THE PRODUCT. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. 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. IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT ALCON. THE HANDPIECE IFU INSTRUCTS: VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY HALF TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS LOADED AND IMPLANTED INTO THE PATIENT WITHOUT ANY OBSERVED ISSUES. HOWEVER, UPON IMPLANTATION, THE SURGEON IDENTIFIED A CRACK ON THE LENS AND PROCEEDED WITH AN IOL EXCHANGE. OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS USED DURING THE LOADING PROCESS, AND NO ABNORMALITIES WERE NOTED AT THAT STAGE. THE AFFECTED LENS WAS REPLACED WITH A PRODUCT FROM A DIFFERENT MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767190 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15261100 00380652422901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CENTURION, ACTIVE SENTRY HANDPIECE.| CLAREON MONARCH IV IOL, INJECTOR.| MONARCH III IOL CARTRIDGE D.| PROVISC OVD.