BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 23566956 · Received November 17, 2025

    Report

    Report Number
    1119421-2025-02953
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    May 12, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652272858
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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 SN6AT3-T9 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 PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED PRIOR TO IMPLANTATION THAT THE IMPLANT WAS PERFORATED. ANOTHER REPLACEMENT IMPLANT WITH THE SAME DIOPTER, SAME MODEL, AND SAME COMPANY WAS USED, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO CLINICAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281910 ACRYSOF IQ TORIC SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN6AT2 15615661 00380652272858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown