BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 22839202 · Received August 19, 2025

    Report

    Report Number
    1119421-2025-02281
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380655093238
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. AND H.11. CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A040609 WAS AN ERROR. IT SHOULD HAVE BEEN A140801 ON THE ORIGINAL MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE HAPTIC WAS DEFORMED OR HAPTIC ABNORMALLY EXTENDED THE SURGEON WAS NOT CONFIDENT IN USING ON PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE TRAILING HAPTIC WAS STUCK, WHILE RETRACT INJECTOR AND PULLING THE LENS OUT THE HAPTIC WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663590 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 15883059 00380655093238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH III IOL , INJECTOR.| MONARCH III IOL, CARTRIDGE C.| VISCOAT OVD.