BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 2980430 · Received February 22, 2013

    Report

    Report Number
    2031924-2013-00034
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS REMOVED INTRAOPERATIVELY DUE TO THE HAPTIC "SNAPPING" OFF. POST OPERATIVE CORNEAL EDEMA WAS NOTED. ADDITIONAL INFO HAS BEEN REQUESTED. REFERENCE MDR #2031924-2013-00035, FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77602 CRYSTALENS ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH & LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other CRYTALSERT CRYSTALENS DELIVERY SYSTEM