BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 20742765 · Received November 21, 2024

    Report

    Report Number
    1119421-2024-02268
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    March 6, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652552523
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED FOR EVALUATION. SOLUTION AND BLOOD ARE DRIED ON THE LENS. THE LENS WAS CLEANED WITH KLRP FOR FURTHER EVALUATION. THE LENS HAS A SCRATCH THAT GOES ACROSS THE POSTERIOR SURFACE OF THE OPTIC. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE FILE INDICATES THE USE OF A NON-QUALIFIED CARTRIDGE. A HANDPIECE AND VISCOELASTIC WAS INDICATED THAT IS QUALIFIED WITH A QUALIFIED CARTRIDGE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. INFORMATION WAS PROVIDED BY THE SURGEON THAT THE ISSUE WAS MOST LIKELY CAUSED BY THE HAPTIC OF SULCUS LENS RUBBING ON THE IRIS/UHG (UVEITIS-GLAUCOMA-HYPHEMA). THE INSTRUCTIONS FOR USE (IFU) STATES THAT THE COMPANY IS A POSTERIOR CHAMBER LENS. INFORMATION WAS PROVIDED THAT THE COMPANY LENS, 20.0 DIOPTER LENS WAS REPLACED WITH A COMPANY LENS, 18.0 DIOPTER ANTERIOR CHAMBER LENS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED VISION BLURRED AND SORE EYE. INITIAL THREE PIECE IOL IMPLANT WAS EXPLANTED AND REPLACED WITH ANTERIOR CHAMBER LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. AS PER THE SURGEON¿S OPINION THE HAPTIC OF SULCUS LENS RUBBING ON IRIS/UGH (UVEITIS-GLAUCOMA-HYPHEMA). ORIGINALLY SCHEDULED PROCEDURE COMPLETED THE SAME DAY. PATIENT'S ISSUES RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430225 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MA60AC 15499545 00380652552523

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention ANTERIOR CHAMBER PMMA IOL.| DUOVISC OVD.| MONARCH III IOL , CARTRIDGE C.| MONARCH III IOL INJECTOR.