BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2040987 · Received March 25, 2011

    Report

    Report Number
    2031924-2011-00076
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 24, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE LENS REVEALED A DIAGONAL TEAR STARTING ON PARTIAL PORTION OF THE LEADING HAPTIC PLATE AND THROUGHOUT THE OPTIC. ALSO, A TEAR THROUGHOUT THE TRAILING HAPTIC PLATE. OBSERVED A PARTIAL PORTION OF THE LEADING HAPTIC PLATE, OPTIC AND A PARTIAL OF THE TRAILING HAPTIC PLATE IS MISSING. UNABLE TO PERFORM OPTICAL MEASUREMENTS DUE TO THE TORN CONDITION OF THE LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE REFRACTIVE ERROR WAS UNPREDICTABLE LENS LOCATION/POSITION.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS IOL IN THE PT'S LEFT EYE. APPROXIMATELY ONE MONTH POSTOPERATIVELY, THE SURGEON EXPLANTED THE LENS DUE TO AN UNINTENDED HYPEROPIC RESULT. THE CRYSTALENS IOL WAS SUCCESSFULLY REPLACED WITH ANOTHER CRYSTALENS OF 29.00 D. THE PT'S PREOPERATIVE BCVA WAS 20/20 - WITH MR OF +2.25 +2.25 X172 POSTOPERATIVELY, THE PT'S BCVA WAS 20/20 WITH MR OF +1.00 +0.75 X163. ACCORDING TO THE SURGEON, THE PT'S OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 019251

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention