BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HQL - INTRAOCULAR LENS

    MDR report key: 3940079 · Received June 20, 2014

    Report

    Report Number
    3003563511-2014-00055
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    April 17, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF A "BROWNISH OPACIFICATION" ON THE LENS IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362440 HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1