BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3082435 · Received April 24, 2013

    Report

    Report Number
    2031924-2013-00082
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 ASYMMETRIC LENS VAULT WAS NOTED FIVE DAYS AFTER IMPLANTATION. THE SURGEON PERFORMED LENS REPOSITION AND ADDED CAPSULAR TENSION RING ON POST-OPERATIVE DAY SEVEN. THE SURGEON EXCHANGED THE CRYSTALENS ON POST-OPERATIVE DAY FOURTEEN WITH A DIFFERENT IOL. AFTER THE LENS EXCHANGE, THE MOST CURRENT VISUAL ACUITY IS 20/20. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175795 CRYSTALENS ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other