BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL-ASPHERIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

    MDR report key: 16323537 · Received February 7, 2023

    Report

    Report Number
    MW5114766
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 3, 2023
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTRAOCULAR LENS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115759 CLAREON IOL-ASPHERIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LLC. SY60WF 21.0

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other