BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON CLAREON INTRA-OCULAR LENS

    MDR report key: 15493672 · Received September 26, 2022

    Report

    Report Number
    MW5112270
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FULL THICKNESS 1MM CRACK 2MM CENTRAL TO IOL OPTIC EDGE, NOT VISUALLY SIGNIFICANT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585433 ALCON CLAREON INTRA-OCULAR LENS INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SY60WF 149T32

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other