BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1910846 · Received November 23, 2010

    Report

    Report Number
    2031924-2010-00201
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT IN (B)(6) 2010 (EXACT DATE NOT PROVIDED). APPROXIMATELY SEVEN MONTHS POSTOPERATIVELY, THE CRYSTALENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT IOL. THE REASON FOR THE REPLACEMENT WAS DUE TO THE PATIENT EXPERIENCING LENS EDGE AWARENESS RESULTING IN NOCTURNAL RINGS AT NIGHT AND GLARE DURING THE DAY. THE PATIENT'S PREOPERATIVE BCVA WAS 20/25, UCVA WAS 20/70 WITH MR + 1.75 - 1.00 X 100. POSTOPERATIVELY, THE PATIENT'S BCVA WAS 20/20, UCVA WAS 20/25 WITH MR - 0.25 - 0.50 X 086. ACCORDING TO THE SURGEON, THE PATIENT'S CURRENT PROGNOSIS IS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB AT50AO 018044

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention