BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 4120856 · Received September 24, 2014

    Report

    Report Number
    3003563511-2014-00064
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(6) PARTNER OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL) OPACIFICATION OF THE IOL IS REPORTED TO HAVE BEEN DETECTED IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594796 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention