BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 3834535 · Received May 2, 2014

    Report

    Report Number
    2031924-2014-00079
    Event Type
    Injury
    Date Received
    May 2, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL AND DIOPTER LENS DUE TO A POSTERIOR VAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264502 CRYSTALENS INTRAOCULAR LENS NAA; LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other