BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 1760586 · Received July 14, 2010

    Report

    Report Number
    1920664-2010-00191
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P880090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LENS WAS ORIGINALLY IMPLANTED ON (B) (6)2010. DUE TO INCORRECT CALCULATION, THE DOCTOR IMPLANTED THE WRONG DIOPTER; THE LENS WAS EXPLANTED AND REPLACED. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTERIOR CHAMBER INTRAOCULAR LENS HQL BAUSCH & LOMB S122UV 2907208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention