BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3476151 · Received November 5, 2013

    Report

    Report Number
    3003563511-2013-00060
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    June 14, 2013
    Report Date
    September 30, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Product Problem
    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 DURING USE OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE IOL HAPTIC BROKE DURING IMPLANTATION. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT 9611165-2013-00107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570702 UNK HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1