BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1913915 · Received November 30, 2010

    Report

    Report Number
    2031924-2010-00213
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS IOL IN THE RIGHT EYE. AT TWELVE MONTHS POSTOPERATIVELY IT WAS NOTED THAT THE CRYSTALENS HAD ASYMMETRICALLY VAULTED (Z-SYNDROME). IN ADDITION, DIFFUSE PCO HAD DEVELOPED. THE PT'S UNCORRECTED VISUAL ACUITY DECREASED FROM 20/30 WITH MR +0.00 -1.50 X 105 AT NINE MONTHS TO 20/60 WITH MR +0.25 -1.75 X 100 AT ONE YR POSTOPERATIVELY. A YAG CAPSULOTOMY IS PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED.

    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