BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L122UV ANTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 2792295 · Received October 12, 2012

    Report

    Report Number
    1119279-2012-00241
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P880090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN L122UV WAS REMOVED INTRAOPERATIVELY DUE TO INTRAOCULAR BLEEDING. SUTURES WERE USED TO CLOSE THE WOUND. NO REPLACEMENT LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L122UV ANTERIOR CHAMBER INTRAOCULAR LENS HQL/IOL-PMMA HQL BAUSCH + LOMB 8U155 2927913

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other