BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 25170634 · Received May 14, 2026

    Report

    Report Number
    1119421-2026-01042
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652272698
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 NOTICED THAT THE OPTICAL ZONE WAS CRACKED. THE SURGERY WAS COMPLETED ON SAME DAY WITH ANOTHER IOL. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246551 ACRYSOF IQ TORIC SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN6AT2 15577927 00380652272698

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B| UNSPECIFIED CARTRIDGE