BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD

    MDR report key: 2023531 · Received March 16, 2011

    Report

    Report Number
    2031924-2011-00048
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    June 11, 2010
    Report Date
    February 16, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL IS IMPLANTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A SECOND OPINION PHYSICIAN REPORTS THAT A PT COMPLAINED OF POOR VISION WITH GLARES AND HALOS APPROX ONE MONTH AFTER CATARACT SURGERIES WITH BILATERAL IMPLANTATION OF CRYSTALENS IOLS. APPROX TWO MONTHS POSTOPERATIVELY THE PT WAS DIAGNOSED WITH CAPSULAR FIBROSIS AND LENS TILTING IN BOTH EYES. THIS REPORT REFERS TO THE LEFT EYE. PREOPERATIVELY, THE PT'S BCVA WAS 20/25 +2 WITH MR OF +2.25 -0.75 X113. APPROX THREE MONTHS POSTOPERATIVELY, THE PT'S UCDVA WAS 20/160, BCDVA WAS 20/20 -1, WITH MR OF -2.25 -1.25 X45. THE PHYSICIAN REPORTS THAT YAG TREATMENT WAS APPLIED APPROX FOUR MONTHS POSTOPERATIVELY WITH NO SIGNIFICANT IMPROVEMENT. ACCORDING TO THE PHYSICIAN, THE PT'S VISION HAS STABILIZED AND THE PT REMAINS UNDER PHYSICIAN'S CARE AND REVIEW. THE PT'S LATEST VISUAL ACUITY APPROX SEVEN MONTHS POSTOPERATIVELY WAS UCDVA 20/50, BCDVA 20/20, MR -1.25 -1.00 X55. PLEASE REFERENCE MANUFACTURER REPORT #: 2031924-2011-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD INTRAOCULAR LENS NAA BAUSCH + LOMB HD500 103183

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention