BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFPORT ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 1891783 · Received October 25, 2010

    Report

    Report Number
    1891783
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LENS INSERTION OF AN ELDERLY PATIENT UNDERGOING RIGHT EYE CATARACT EXTRACTION WITH LENS IMPLANT AND VITRECTOMY IN AMBULATORY SURGERY SETTING, THE IMPLANT BROKE AND SURGEON REPLACED WITH NEW LENS. THE SURGEON INSPECTED THE EYE AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT ADVANCED OPTICS ASPHERIC LENS LENS, INTRAOCULAR, IMPLANT HQL BAUSCH & LOMB PC- LI61AO 4015506

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR