BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 3769430 · Received April 16, 2014

    Report

    Report Number
    3003563511-2014-00048
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    April 7, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION RECEIVED AS PROVIDED TO THE DISTRIBUTOR BY THE HEALTHCARE PROFESSIONAL STATES THAT THE CENTRE OF THE IMPLANTED LENS WAS FOUND TO BECOME "DULL" FOLLOWING DSAEK SURGERY AND INSERTION OF SF6 GAS. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR # 9611165-2014-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233389 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention