BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD

    MDR report key: 1961011 · Received January 11, 2011

    Report

    Report Number
    2031924-2011-00019
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE SURGEON, THE LIKELY CAUSE OF THE EVENT IS DUE TO THE LENS POSITION. THE INTRAOCULAR LENS IS IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS INTRAOCULAR LENS IN THE RIGHT EYE. APPROX ONE MONTH POSTOPERATIVELY, THE INTRAOCULAR LENS VAULTED AND A REFRACTIVE ERROR WAS NOTED. PREOPERATIVELY, THE PATIENT'S BCVA WAS 20/40 WITH MR -0.25 - 0.50 X 135. POSTOPERATIVELY, THE PATIENT'S BCDVA WAS 20/30 WITH MR - 1.25 SPHERE. THE PT REPORTS EXPERIENCING BLURRY VISION AND HAS BEEN PRESCRIBED GLASSES TO CORRECT MYOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD INTRAOCULAR LENS NAA BAUSCH + LOMB HD520 019116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other