BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 3760637 · Received April 10, 2014

    Report

    Report Number
    3003563511-2014-00045
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 27, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD
    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 DURING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE HEALTHCARE FACILITY REPORTS THAT THE SURGEON INJECTED THE LENS AND DURING INJECTION HEARD A POPPING SOUND. THE HEALTHCARE PROFESSIONAL STATES THAT THE POSTERIOR CAPSULE RUPTURED DURING INJECTION AND THAT THE LENS WENT INTO THE VITREOUS. FOR FURTHER IN INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216253 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention