BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1936256 · Received December 14, 2010

    Report

    Report Number
    2031924-2010-00230
    Event Type
    Injury
    Date Received
    December 14, 2010
    Report Date
    November 14, 2010
    Manufacturer
    BAUCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SECONDARY PHYSICIAN REPORTS A PT THAT WAS IMPLANTED WITH A CRYSTALENS ONE YEAR AGO, IS EXPERIENCING DECREASED VISION WITH BEST CORRECTED VISUAL ACUITY OF A MURKY 20/40. THE PHYSICIAN FOUND POSSIBLE LENS DEBRIS OR POSSIBLY ELSCHNIG PEARLS COVERING THE BACK OF THE LENS OPTIC, WHICH COULD EXPLAIN THE DECLINE IN VISION. SINCE SURGERY THE PT UNDERWENT TWO YAG CAPSULOTOMIES AND A LASIK PROCEDURE. A NEURO-OPHTHALMOLOGIC SPECIALIST RULED OUT OPTIC NERVE AND RETINAL PATHOLOGY. IT HAS NOW BEEN SUGGESTED TO THE PT TO SEEK EXPERT CONSULTATION FOR A POSSIBLE LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUCH & LOMB HD500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention