BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3042074 · Received April 3, 2013

    Report

    Report Number
    2031924-2013-00068
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAUSCH+LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED AND WILL THEREFORE NOT BE RETURNED TO B+L 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

    THE PT REPORTED THAT FOLLOWING BILATERAL IOL IMPLANTATION, HIS VISION WAS INITIALLY GOOD BUT "SEEMED TO DIMINISH OVER TIME." A PROCEDURE WAS ALLEGEDLY PERFORMED BUT NO DETAILS WERE PROVIDED. THIS EVENT PERTAINS TO THE PT'S RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR# 2031924-2013-00067 FOR THE INTRAOCULAR LENS IMPLANTED IN THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135924 CRYSTALENS ACCOMMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH+LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other