BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS / ACCOMMODATING IOL

    MDR report key: 2929640 · Received January 18, 2013

    Report

    Report Number
    2031924-2013-00022
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT PRESENTED WITH GLARE APPROX ONE YEAR POST CRYSTALENS IMPLANTATION. REPOSITIONING OF THE LENS WAS PERFORMED 30 DAYS POST ORIGINAL PROCEDURE TO ADDRESS VAULTING. BCVA PRIOR TO THE LENS REPOSITIONING WAS 20/20. YAG FOR PCO WAS PERFORMED SEVEN MONTHS POSTOPERATIVELY LEAVING 3-4 "PITS" ON LENS SURFACE POST PROCEDURE. THE MOST CURRENT BCVA IS 20/20 ((B)(6) 2012). ACCORDING TO THE SURGEON PT DESIRES TO HAVE LENS REMOVED DUE TO PERSISTENT GLARE DESPITE CONVENTIONAL TREATMENTS (ALPHAGAN, YAG). THIS REPORT PERTAINS TO THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27592 CRYSTALENS / ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other