BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 23110505 · Received September 22, 2025

    Report

    Report Number
    1119421-2025-02543
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    April 22, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN A.1., A.2., A.3.A., B.3., B.5., D.10., H.3., H.6., AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION STATEMENT WAS PROVIDED IN H.11. UPON FURTHER REVIEW OF AVAILABLE INFORMATION LENS WAS JAMMED INTO INJECTOR WITH NO PATIENT CONTACT AND NO PATIENT HARM, THE EVENT WHICH IS UNDERSTOOD AS BEING ASSOCIATED WITH PRIMING THE DEVICE AND IS CONSIDERED PRIOR TO USE. BASED ON THIS INFORMATION THIS EVENT NO LONGER MEETS REPORTING CRITERIA PER APPLICABLE REGULATION, BECAUSE THERE IS NO EVIDENCE OF A LIFE THREATENING INJURY/ILLNESS OR PERMANENT IMPAIRMENT/DAMAGE, THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT/DAMAGE AND THE INFORMATION PROVIDED DOES NOT REPRESENT A PRODUCT PROBLEM THAT IS LIKELY TO CAUSE THE ABOVE-MENTIONED EVENTS IF THE PRODUCT PROBLEM WERE TO RECUR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT AND HARM.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS JAMMED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594392 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SA60AT 15891993

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DUOVISC VISCOELASTIC SYSTEM| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| UNSPECIFIED INJECTOR