BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 20514570 · Received October 23, 2024

    Report

    Report Number
    1119421-2024-02056
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422697
    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

    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). 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) CAME OUT WITH SCRATCHES ON THE OPTIC DURING INJECTION. THE HOSPITAL DID NOT EXCHANGE THE IOL, AS THEY SAID THEY WOULD WAIT AND SEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36446 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15193878 00380652422697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown