BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 3890635 · Received May 30, 2014

    Report

    Report Number
    2031924-2014-00112
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS EXPLANTED AS THE PT WAS NOT HAPPY WITH HER VISUAL OUTCOME. THE PT FELT SHE COULD BOTH FEEL AND SEE THE LENS AT ALL TIMES. THIS REPORT PERTAINS TO THE PT'S RIGHT EYE. ADDITIONAL INFO HAS BEEN REQUESTED, NO ADDITIONAL INFO HAS BEEN RECEIVED BY BAUSCH + LOMB TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319892 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other