BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061202 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00219
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2007
    Report Date
    May 19, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE PATIENT'S COMPLAINTS ARE LIKELY ATTRIBUTED TO PRE-EXISTING CORNEAL ASTIGMATISM AND PRE-EXISTING DIFFICULTIES WITH NIGHT VISION (HALOS, GLARE).

    Description of Event or Problem · 1

    A PATIENT REPORTS UNDERGOING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. IMMEDIATELY POSTOPERATIVELY, THE PATIENT COMPLAINED OF GLARE AND HALOS. PATIENT ALSO REPORTS EXPERIENCING DIFFICULTY WITH NIGHT DRIVING, STARBURSTS, FLOATERS, DRY EYE SYMPTOMS, AND A NEED FOR READING GLASSES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE IMPLANTING PHYSICIAN, WHO REPORTS THAT THE PATIENT'S PREOPERATIVE BCVA OS WAS 20/25-2, MRSE WAS -4.50 + 0.50 X 085. POSTOPERATIVELY, THE PATIENT'S BCVA OS WAS 20/25 AND J6, MRSE WAS PLANO + 0.25 X 074. A YAG CAPSULOTOMY WAS PERFORMED OS IN 2007, AND THE BCVA IMPROVED TO 20/25, J5 AND MRSE IMPROVED TO +0.25 +0.25 X 075. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE PATIENT'S SYMPTOMS ARE MULTIFACTORIAL - CORNEAL ASTIGMATISM (PRE-EXISTING CONDITION) AND DRY EYE SYNDROME. THE HALOS ARE NOT BELIEVED TO BE LENS RELATED. REFERENCE MDR #2031924-2008-00215.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT52SE 007513

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention