BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 24925860 · Received April 20, 2026

    Report

    Report Number
    1119421-2026-00822
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    September 17, 2025
    Report Date
    April 20, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652394864
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN H.6. AND H.11. ON INITIAL MDR SUBMITTED THE PRODUCT CODE SHOULD BE A150204 INSTEAD OF A140801. BASED ON AVAILABLE INFORMATION FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A MALFUNCTION PER REGULATION. NO FURTHER REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS NOT PLACED DUE TO NOT PROPERLY OUT OF SHOOTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND NO CONSEQUENCES FOR THE PATIENT. THE SURGERY COMPLETED USING THE BACKUP IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601164 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 16002477 00380652394864

    Patients

    Seq Age Sex Outcome Treatment
    1