BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAUSCH AND LOMB LENS ENVISTA

    MDR report key: 21826549 · Received April 11, 2025

    Report

    Report Number
    MW5168898
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 7, 2025
    Manufacturer
    INTRAOCULAR LENS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED INFLAMMATION POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121753 BAUSCH AND LOMB LENS ENVISTA INTRAOCULAR LENS HQL INTRAOCULAR LENS

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Other