BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMODATING IOL

    MDR report key: 3113628 · Received May 9, 2013

    Report

    Report Number
    2031924-2013-00083
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO BAUSCH + LOMB FOR EVAL. 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 WAS REMOVED FROM THE PT'S LEFT EYE INTRAOPERATIVELY DUE TO A POSTERIOR CAPSULE RUPTURE. THE REPORTER WAS UNCERTAIN WHETHER THE CAPSULE RUPTURE OCCURRED PRIOR TO OR DURING IOL INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND A DIFFERENT MODEL LENS WAS SUCCESSFULLY IMPLANTED. THE PT'S MOST CURRENT BCVA WAS 20/20. PLEASE REFERENCE MDR#: 2031924-2013-00084 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204705 CRYSTALENS ACCOMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMADATIVE NAA BAUSCH + LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other CRYSTALSERT DELIVERY SYSTEM, CI-28