BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 2950309 · Received February 6, 2013

    Report

    Report Number
    2031924-2013-00025
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 23, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 Z-SYNDROME WAS NOTED APPROX 3 WEEKS POST IMPLANTATION OF THE IOL IN THE PT'S LEFT EYE. APPROX 2 WEEKS LATER THE LENS WAS EXCHANGED FOR ANOTHER LENS OF THE SAME DIOPTER POWER AND MODEL. BEFORE THE LENS WAS EXCHANGED THE BCVA WAS 20/30-2. ACCORDING TO THE SURGEON, THE PT'S PROGNOSIS IS VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50845 CRYSTALENS ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other