BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1833675 · Received September 10, 2010

    Report

    Report Number
    2031924-2010-00158
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE WAS RETURNED TO B+L AND SUBJECTED TO VISUAL EXAMINATION. RESULTS REVEALED THAT ONLY HALF OF THE OPTIC AND ONE HAPTIC PLATE/HAPTIC WAS RETURNED. THE CONDITION OF THE LENS IS CONSISTENT WITH LENSES THAT HAVE BEEN REMOVED FROM THE EYE. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. POSTOPERATIVELY, THE PATIENT COMPLAINED OF GLARE AND THE CRYSTALENS WAS REMOVED AND REPLACED WITH A DIFFERENT LENS MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention