BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 1901433 · Received November 11, 2010

    Report

    Report Number
    9611165-2010-00024
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 10, 2010
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA REGARDING THE INJECTOR USED DURING THE IMPLANTATION IS NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE TECHNICIAN LOADED THE LENS INTO THE INJECTOR AND HANDED THE INJECTOR TO THE SURGEON. UPON IMPLANTING THE LENS, THE SURGEON NOTICED THAT THE LENS WAS DAMAGED. THE SURGEON REMOVED THE LENS BY INCREASING THE SIZE OF THE INCISION AND REMOVING THE LENS AS A COMPLETE UNIT. THE SURGEON THEN SUCCESSFULLY IMPLANTED A BACK-UP LENS. THE SURGEON AND PATIENT WERE SATISFIED WITH THE OUTCOME OF THE PROCEDURE. THE LENS WAS DESTROYED BY THE SURGEON FOLLOWING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 570C 039E8811504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other