BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1213969 · Received October 28, 2008

    Report

    Report Number
    2031924-2008-00298
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT EYE. PHYSICIAN NOTES LARGE CAPSULORHEXIS. NINE WEEKS POSTOPERATIVELY, THE LENS VAULTED IN A Z CONFIGURATION AND REQUIRED INTERVENTION TO EXCHANGE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL HD500 014338

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention