BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3634576 · Received January 31, 2014

    Report

    Report Number
    3003563511-2014-00003
    Event Type
    Injury
    Date Received
    January 31, 2014
    Report Date
    December 20, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD 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 PROVIDED STATES THAT THE SURGEON OBSERVED SECONDARY CATARACT (POSTERIOR CAPSULE OPACIFICATION - PCO) IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFORMATION, PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68587 NA HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1