BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2103666 · Received May 20, 2011

    Report

    Report Number
    2031924-2011-00100
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    February 4, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL IS IMPLANTED, THEREFORE, IT IS NOT AVAILABLE FOR EVAL. IN ADDITION, THE SERIAL NUMBER OR LOT NUMBER OF THE IOL WERE NOT PROVIDED. THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTS THAT HE HAD CATARACT REMOVAL AND CRYSTALENS IMPLANTED IN THE LEFT EYE. ONE DAY POST OPERATION, THE PT INFORMED THE SURGEON THAT THE OUTER CORNER OF HIS LEFT EYE FELT SWOLLEN. THE PT INDICATED ON HIS TWO MONTH POST-OPERATIVE OFFICE VISIT THAT HE ONLY SEES A LITTLE BETTER AND HIS EYE STILL FEELS SWOLLEN. THE SURGEON ADVISED HIM TO CONTINUE EYE DROPS FOR TWO MORE WEEKS. PT REPORTS THAT AS OF (B)(6), 2011, HE FEELS NO IMPROVEMENT; PATIENT ALSO REPORTS THAT HIS EYES FEEL DRY/BURN AND STRAINING AND HE SEES MORE SPOTS OR SHADOWS THAN BEFORE THE PROCEDURE. ADD'L INFO HAS BEEN REQUESTED BUT HAS NOT BEEN REC'D. PLEASE REFERENCE MDR#: 2031924-2011-00101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CRYSTALENS