BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1071545 · Received July 8, 2008

    Report

    Report Number
    2031924-2008-00236
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 13, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE LIKELY CAUSE OF THE EVENT WAS ATTRIBUTED TO THE NASAL HINGE OF THE IOL, WHICH CAUSES ANTERIOR VAULT IN ITS NATURAL POSITION.

    Description of Event or Problem · 1

    A RELATIVE REPORTS THAT HIS DAUGHTER UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. IMMEDIATELY POSTOPERATIVELY, THE PT EXPERIENCED BLURRY VISION. THE PT REPORTS THAT THE PHYSICIAN INDICATED THE ORIGINAL CRYSTALENS IMPLANT WAS DEFECTIVE AND NEEDED TO BE REMOVED. THE LENS WAS EXCHANGED FOR THE SAME DIOPTER CRYSTALENS AND THE PT'S VISION IMPROVED. ADDITIONAL INFO WAS PROVIDED BY THE PHYSICIAN WHO REPORTS THAT ONE DAY POSTOP, THE LENS WAS OBSERVED IN THE Z POSITION, WITH ONE HAPTIC ANTERIOR. THE PATIENT'S PREOPERATIVE BCVA WAS 20/40, AND MRSE WAS -3.50 + 1.00 X 040. A LENS REPOSITIONING WAS ATTEMPTED, BUT WAS NOT SUCCESSFUL AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER CRYSTALENS AND A SUTURE WAS PLACED. PRIOR TO THE LENS REPLACEMENT, THE PATIENT'S BCVA HAD IMPROVED TO 20/25, HOWEVER, MRSE WAS -3.25 + 2.00 X 010. THE PATIENT'S PROGNOSIS IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 010168

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention