BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1250397 · Received December 3, 2008

    Report

    Report Number
    2031924-2008-00325
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 5, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    A PHYSICIAN REPORTS THAT A PATIENT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. IMMEDIATELY POSTOPERATIVELY THE PATIENT REPORTED A DECREASE IN VISION. FIVE DAYS POSTOPERATIVELY, THE LENS WAS EXCHANGED FOR ANOTHER CRYSTALENS (DIOPTER UNKNOWN). REASON PROVIDED WAS "WRONG DIOPTER POWER". UNKNOWN IF THIS IS A LENS CALCULATION ERROR OR LABELING ISSUE. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL AT50SE 008350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention