BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1358536 · Received April 8, 2009

    Report

    Report Number
    2031924-2009-00046
    Event Type
    Injury
    Date Received
    April 8, 2009
    Date of Event
    October 23, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM. OTHER: SUTURES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS TRAILING HAPTIC TORE DURING INSERTION WITH THE STAAR SURGICAL LENS INJECTOR SYSTEM. FOUR ADDITIONAL LENSES WERE DAMAGED IN THE SAME MANNER. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION, REMOVE THE DAMAGED LENSES, AND SUTURE THE INCISION. A NEW CRYSTALENS WAS IMPLANTED SUCCESSFULLY ON A LATER DATE AND THE PATIENT'S PROGNOSIS IS EXCELLENT. REFERENCE MDRS: #2031924-2009-00043, # 2031924-2009-00044, #2031924-2009-00045, #2031924-2009-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL HD500 015740

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention MICROSERT LENS INJECTOR SYSTEM (STAAR)