BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 3769452 · Received April 16, 2014

    Report

    Report Number
    3003563511-2014-00051
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    April 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 A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE PT'S VISUAL OUTCOME POST-OPERATIVELY IS NOT AS INTENDED. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR # 9611165-2014-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233391 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 920H NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention