BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 3113614 · Received May 9, 2013

    Report

    Report Number
    2031924-2013-00084
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS REQUESTED, BUT HAS NOT RETURNED TO BAUSCH + LOMB. 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#: 2031924-2013-00083 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204672 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other CRYSTALENS ACCOMODATING IOL