BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3853014 · Received May 23, 2014

    Report

    Report Number
    2031924-2014-00105
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    October 1, 2013
    Report Date
    April 23, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE LENS BECAME VAULTED ASSYMETRICALLY (Z-SYNDROME) APPROXIMATELY 30 DAYS POST IMPLANT. THE SURGEON PERFORMED YAG AND REPOSITIONED THE LENS. THIS REPORT PERTAIN TO THE PT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309109 CRYSTALENS ACCOMMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other