BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAUSCH & LOMB SOFLEX IOL

    MDR report key: 2004013 · Received February 22, 2011

    Report

    Report Number
    MW5019573
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    April 13, 2010
    Report Date
    February 23, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    LENS RECALL (B)(6) 2009. PUT IN EYE OF MY HUSBAND, (B)(6) 2010 AFTER CATARACT SURGERY, CAPSULE RUPTURED BY SURGEON'S ERROR. EYE PRESSURES WENT INTO THE 60'S, AND THERE WAS A MFG DEFECT TO THE HAPTIC ARM OF THE IOL. NOT ON THE RECALL NOTICE. WILL FAX TO A REP - MED REPORT. RECALL # 2-0591-2010

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAUSCH & LOMB SOFLEX IOL SOFLEX 6E FOLDABLE INTRAOCULAR LENS SE HQL BAUSCH & LOMB L161SE 4916928

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R| S