BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2051184 · Received April 6, 2011

    Report

    Report Number
    2031924-2011-00084
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAUSCH & LOMB
    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 SURGEON DID NOT INDICATE THAT THERE WERE ANY ISSUES WITH THE CRYSTALENS IOL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. THE LENS WAS RETURNED TO B+L AND SUBJECTED TO VISUAL INSPECTION. RESULTS REVEALED TWO TEARS ON THE LEADING HAPTIC PLATE, A TEAR IN ZONE ONE OF THE OPTIC, AND A TEAR ON THE EDGE OF THE TRAILING PLATE. THE INSERTER DEVICE WAS NOT RETURNED. OTHER - TORN.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS IN THE LEFT EYE. INTRAOPERATIVELY, THE SURGEON NOTED THE CAPSULE BAG WAS UNSTABLE DUE TO A SMALL TEAR. THE CRYSTALENS IOL WAS REMOVED AND A DIFFERENT IOL WAS IMPLANTED SUCCESSFULLY. ACCORDING TO THE SURGEON, THE PT'S PROGNOSIS IS GOOD. REFERENCE MDR # 2031924-2011-00085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB AT52AO 019617

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other CI-28 INSERTER