BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1180935 · Received September 22, 2008

    Report

    Report Number
    2031924-2008-00288
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTS THAT WHEN OPENING THE LENS PACKAGING, THE CRYSTALENS HAPTIC BROKE. NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL AT50SE

    Patients

    Seq Age Sex Outcome Treatment
    1