BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 2192724 · Received July 22, 2011

    Report

    Report Number
    9611165-2011-00012
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE LENS HAPTIC TORE DURING THE PROCEDURE. THERE WAS REPORTED TO BE NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-FLEX ASPHERIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 573T 099E9363922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention