BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2023373 · Received March 16, 2011

    Report

    Report Number
    2031924-2011-00067
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BAUSCH & LOMB RECEIVED COMMUNICATION FROM A CONSUMER WHO IS DISSATISFIED WITH HIS VISUAL OUTCOME AFTER CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS IOL IN THE LEFT EYE. THE PT COMPLAINS TO POOR NEAR VISION AND DIFFICULTY READING. INFO RECEIVED FROM THE OPERATING PHYSICIAN INDICATES THAT THE LENS MAY HAVE VAULTED AND IS NOT FLEXING TO ACCOMMODATE. PREOPERATIVELY, THE PT'S BCVA WAS 20/40 WITH MR OF PL + 1.00 X 180. POSTOPERATIVELY, THE PT'S BCVA IS 20/25 WITH MR OF -0.25 SPHERE. ACCORDING TO THE SURGEON, THE PT'S CURRENT PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB AT50AO 019417

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention