BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N

    MDR report key: 3674496 · Received February 20, 2014

    Report

    Report Number
    3003563511-2014-00005
    Event Type
    Injury
    Date Received
    February 20, 2014
    Report Date
    January 9, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE HEALTHCARE FACILITY REPORTS THAT IN THE POST-OPERATIVE PERIOD, THE IOL WAS FOUND TO HAVE OPACIFIED. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106508 N HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1