BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3453091 · Received October 23, 2013

    Report

    Report Number
    3003563511-2013-00045
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 23, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    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 DURING IMPLANTATION OF RAYNER INTRAOCULAR LENS (IOL) HAPTIC BROKE DURING IMPLANTATION. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT 9611165-2013-00092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543431 UNKNOWN HQL- INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1