BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    MDR report key: 22122761 · Received June 2, 2025

    Report

    Report Number
    1119421-2025-01566
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652422925
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PHOTOS WERE PROVIDED OF THE DAMAGED LENS. THE YELLOW SINGLE PIECE LENS WAS SHOWN BEING HELD OVER THE EYE WITH INSTRUMENTS. THE OPTIC APPEARED CRACKED/BROKEN IN THE CENTER AND BROKEN OR TORN ON EDGE. THIS DAMAGE WAS SIMILAR TO DAMAGE THAT MAY OCCUR WITH A PLUNGER OVER OR UNDERRIDE. 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 PROVIDED. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. PHOTOS WERE PROVIDED OF THE DAMAGED LENS. THE YELLOW SINGLE PIECE LENS WAS SHOWN BEING HELD OVER THE EYE WITH INSTRUMENTS. THE OPTIC APPEARED CRACKED/BROKEN IN THE CENTER AND BROKEN OR TORN ON EDGE. THIS DAMAGE WAS SIMILAR TO DAMAGE THAT MAY OCCUR WITH A PLUNGER OVER OR UNDERRIDE. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE IFU INSTRUCTS: COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH A 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 MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS BROKEN IN CENTER. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844578 ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT215 15768836 00380652422925

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown