BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1892052 · Received October 26, 2010

    Report

    Report Number
    2031924-2010-00180
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS IN THE RIGHT EYE. POSTOPERATIVELY, THE LENS VAULTED AND A CAPSULAR TENSION RING WAS INSERTED. THE PATIENT'S PREOPERATIVE BCVA WAS 20/30- WITH MR -1.00 - 1.25 X 097. POSTOPERATIVELY (PRIOR TO ANY INTERVENTIONS) THE PATIENT'S BCVA WAS 20/30 WITH MR -1.75 + 1.50 X 180. THE PATIENT'S CURRENT BCVA IS 20/40 WITH MR -2.00 + 1.50 X 180. THE SURGEON IS PLANNING TO EXCHANGE THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB HD500 017147

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention