BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3503462 · Received November 18, 2013

    Report

    Report Number
    3003563511-2013-00062
    Event Type
    Injury
    Date Received
    November 18, 2013
    Report Date
    October 17, 2013
    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 EVENT DESCRIPTION RECEIVED STATES THAT IOL WAS EXPLANTED DUE TO THE DEVELOPMENT OF POSTERIOR CAPSULE OPACIFICATION. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT # 9611165-2013-00109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595595 UNKNOWN HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention