BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1220455 · Received November 4, 2008

    Report

    Report Number
    2031924-2008-00318
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE REPORTED PROBLEM OF LENS VAULTING WAS LIKELY DUE TO CAPSULAR CONTRACTION SYNDROME.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CYSTALENS. APPROX ONE MONTH POSTOPERATIVELY, THE PT'S REFRACTION GRADUALLY CHANGED AND THE PT COMPLAINED OF A CIRCLE CENTRALLY. PREOPERATIVELY, THE PT'S BCVA WAS 20/20-2 AND MRSE WAS + 0.25 SPH. POSTOPERATIVELY, THE BCVA DECREASED TO 20/50 AND MRSE CHANGED TO -1.50 -3.50X 178. THE LENS WAS NOT ABLE TO BE REPOSITIONED AND WAS SUBSEQUENTLY ECHANGED FOR A DIFFERENT LENS MODEL IN 2008. AFTER THE LENS EXCHANGE, THE BCVA IMPROVED TO 20/30, J3, AND THE MRSE IMPROVED TO PLANO- 0.75 X 0044. PHYSICIAN CITES CAUSE OF EVENT AS "POSSIBLE CAPSULAR CONTRACTION SYNDROME". THE PT'S PROGNOSIS IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL HD500 015115

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention