BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 23050582 · Received September 15, 2025

    Report

    Report Number
    1119421-2025-02468
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    July 1, 2023
    Report Date
    October 15, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652421638
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B.5., AND H.11. BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A SERIOUS INJURY/MALFUNCTION. NO FURTHER REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, AND FILE WAS REASSESSED AS IT WAS NOTED THAT THE MACULAR EDEMA HAD NOTHING TO DO WITH THE IOL. IT WAS A CASE OF AGE-RELATED MACULAR DEGENERATION. IT HAS BEEN DETERMINED THAT THERE IS NO REPORTED COMPLAINT OR DEFECT WITH THE PRODUCT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD SOUGHT A SECOND OPINION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT DEVELOPED MACULAR EDEMA. A FLUORESCENT ANGIOGRAPHY (FAG) WAS ORDERED. THE PATIENT DECIDED TO SEE ANOTHER OPHTHALMOLOGIST. THE FLUORESCENT ANGIOGRAPHY (FAG) WAS THEN PERFORMED AT A DIFFERENT EYE CENTER. LENS REMAIN IMPLANTED IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952204 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT315 15363129 00380652421638

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other MONARCH III IOL, CARTRIDGE D| MONARCH III IOL, INJECTOR