BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1895403 · Received November 4, 2010

    Report

    Report Number
    2031924-2010-00194
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. ONE MONTH POSTOPERATIVELY ((B)(6) 2010), THE PT'S UDVA WAS 20/30 J3, UIVA 20/25 WITH MR - 1.00 - 0.25 X 110. A F/U EXAMINATION WAS PERFORMED ON (B)(6) 2010. AT THIS VISIT, THE PT COMPLAINED OF SUDDEN ONSET OF BLURRED VISION AND THE SURGEON OBSERVED THAT THE LENS HAD VAULTED ANTERIORLY. THE PT'S UDVA DECREASED TO 20/70, UIVA WAS 20/50 J2 WITH MR - 2.25 -0.50 X 160. THE SURGEON PERFORMED A YAG CAPSULOTOMY UNDER THE SUPERIOR HINGE WITH THE INTENT OF RETURNING THE IOL TO A MORE POSTERIOR POSITION. THE PT CONTINUES TO BE MONITORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention