BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 3698327 · Received March 11, 2014

    Report

    Report Number
    3003563511-2014-00038
    Event Type
    Injury
    Date Received
    March 11, 2014
    Report Date
    January 20, 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 DURING USE OF A C-FLEX 570C INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT THE LENS HAPTIC GOT CAUGHT DURING IMPLANTATION. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MED 9611165-2014-00038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146267 C-FLEX HQL-INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 570C NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1