BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2103668 · Received May 20, 2011

    Report

    Report Number
    2031924-2011-00102
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    September 13, 2010
    Report Date
    April 28, 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 AND THEREFORE, IT IS NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED AND IF PROVIDED, WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTS HAVING INFLAMMATION, HAZE, AND SOMETIMES BLURRED VISION AFTER HAVING BEEN IMPLANTED WITH A CRYSTALENS IOL IN HIS RIGHT EYE. THE PT DESCRIBED HIS NEAR VISION AS POOR AND DISTANCE VISION AS LESS THAN SATISFACTORY. THE PT WAS GIVEN ANTI-INFLAMMATORY EYE DROPS POST SURGERY. THE PT CONTINUED TO EXPERIENCE HAZINESS, AND WAS PRESCRIBED ATROPINE SULFATE OPHTHALMIC SOLUTION FOR ABOUT THREE WEEKS. APPROX SIX MONTHS POST-OPERATION, THE PT REC'D YAG LASER TREATMENT FOR POSTERIOR CAPSULE OPACIFICATION. ACCORDING TO THE PT, HIS SYMPTOMS DID NOT IMPROVE AFTER THE YAG TREATMENT. THE PT WAS REFERRED TO A CORNEA SPECIALIST FOR EVAL ON (B)(6) 2011. NO PROBLEMS WERE FOUND BY THE CORNEA SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other