BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3834514 · Received May 2, 2014

    Report

    Report Number
    2031924-2014-00084
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE CRYSTALENS VAULTED (Z-SYNDROME) APPROXIMATELY 2 MONTHS POST LENS IMPLANT. THE PATIENT NOTICED A DECREASE IN HER VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MODEL LENS. THE SURGEON INDICATED THAT THE LIKELY CAUSE OF THE EVENT WAS "EXTREME FIBROSIS." THE PATIENT'S CURRENT PROGNOSIS IS DESCRIBED AS "GOOD VISUAL ACUITY." THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264501 CRYSTALENS ACCOMMODATING IOL NAA; LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other