BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1833676 · Received September 10, 2010

    Report

    Report Number
    2031924-2010-00157
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    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 THAT RELATE TO THE REPORTED ISSUE. ROOT CAUSE: ACCORDING TO THE SURGEON, THE LIKELY ROOT CAUSE OF THE REPORTED CAPSULE DAMAGE AND LENS DROP IS THE LENS HAPTIC CAUGHT ON THE ANTERIOR CAPSULE AND WHEN TRYING TO REPOSITION IT, THE LENS FLIPPED FORWARD AND LACERATED THE POSTERIOR CAPSULAR BAG. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. DURING INSERTION AND POSITIONING OF THE CRYSTALENS, THE HAPTIC/PLATE CLOSEST TO THE PHACO WOUND TORE THE POSTERIOR CAPSULE AND THE LENS DROPPED INTO THE POSTERIOR SEGMENT. THE SURGEON ELECTED TO LEAVE THE CRYSTALENS IN THE POSTERIOR SEGMENT AND IMPLANTED A DIFFERENT LENS MODEL IN THE SULCUS AND PERFORMED A VITRECTOMY. THE PATIENT WAS THEN REFERRED TO A RETINAL SPECIALIST WHERE THE PATIENT UNDERWENT SECONDARY SURGICAL INTERVENTION TO REMOVE THE CRYSTALENS FROM THE POSTERIOR SEGMENT. THE PATIENT HAS IMPROVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT52AO 018772

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention