BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 21705845 · Received March 27, 2025

    Report

    Report Number
    1119421-2025-00850
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 27, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422673
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    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. 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).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT THERE WAS PROBLEM LOADING TRAILING HAPTIC AND HAPTIC BROKEN. LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE SURGERY WAS COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470580 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15177170 00380652422673

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED REPLACEMENT IOL