BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 22206551 · Received June 13, 2025

    Report

    Report Number
    1119421-2025-01667
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422888
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    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. A PROVIDED PHOTO SHOWS THE LENS STILL IN THE EYE. THE OPTIC EDGE HAS TWO DEEP SCRAPE MARKS OR CRACKS. 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 DAT315-615 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6., B.5. ADDITIONAL INFORMATION PROVIDED IN H.3., H.11. PHYSICIAN STATED BROKEN EDGE WAS FOUND AFTER IMPLANTATION. THE PRODUCT WAS NOT RETURNED. A PHOTO WAS PROVIDED. THE PHOTO SHOWED AN IMPLANTED TORIC LENS MODEL. THE OPTIC EDGE HAS TWO CRACKS AREAS ON OPPOSITE SIDE OF THE OPTIC. THE LOCATION OF THE DAMAGE ANGLED TO THE TRAVEL PATH MAY INDICATE A PLUNGER OVERRIDE OCCURRED. A PRODUCT HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. ASSOCIATED PRODUCTS WERE NOT PROVIDE. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. BASED ON REVIEW OF THE PROVIDED PHOTO, THE OPTIC WAS CRACKED ON OPPOSITE EDGES. THE ROOT CAUSE FOR THE OBSERVED DAMAGE CANNOT BE DETERMINED FROM THE PHOTO. THE LOCATION OF THE DAMAGE ANGLED TO THE TRAVEL PATH MAY INDICATE A PLUNGER OVERRIDE OCCURRED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE INSTRUCTION FOR USE (IFU) INSTRUCTS: 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 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 COMPANY. 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 ½ 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 SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE BROKEN EDGE OF LENS AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW OF THE INITIALLY RECEIVED INFORMATION, IT WAS IDENTIFIED THAT THE PROCEDURE HAD BEEN COMPLETED WITH THE SAME LENS ON THE SAME DAY (PREVIOUSLY REPORTED AS EXPLANTED DURING INITIAL PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354267 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15658983 00380652422888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown