BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT AVAILABLE

    MDR report key: 3940107 · Received June 20, 2014

    Report

    Report Number
    3003563511-2014-00057
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE DISTRIBUTOR IN (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER IOL. THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE POST-OPERATIVE DEVELOPMENT OF OPACIFICATION. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER'S MDR 9611165-2014-00057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362455 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1