BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1153106 · Received September 8, 2008

    Report

    Report Number
    2031924-2008-00279
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 14, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE LIKELY ROOT CAUSE OF THE LENS VAULTING WAS RELATED TO INFERIOR FIBROSIS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PT UNDERWENT CATARACT SURGERY WITH PLACEMENT WITH CRYSTALENS IN THE LEFT EYE. TWO WEEKS POSTOPERATIVELY, THE LENS VAULTED ANTERIORLY, RESULTING IN A MYOPIC OUTCOME. PREOPERATIVELY, THE PT'S BCVA WAS 20/50- AND MRSE WAS +2.75 -0.75 X 070. AFTER THE LENS VAULTED, THE PT'S BCVA WAS 20/20, HOWEVER, MRSE DECREASED TO -3.25 - 0.50 X 090. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LENS, BUT WAS NOT SUCCESSFUL AND THE LENS WAS EXCHANGED SUCCESSFULLY FOR A SULCUS-FIXATED INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 012411

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention