BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2190160 · Received February 9, 2007

    Report

    Report Number
    2031924-2007-00007
    Event Type
    Injury
    Date Received
    February 9, 2007
    Date of Event
    June 30, 2006
    Report Date
    January 10, 2007
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INFO FOR OD EYE: MODEL #: AT45SE; LOT #: 002923; CATALOG #: AT45SE; EXP DATE: 02/28/2011; SERIAL #: (B)(4); OTHER #: (B)(4). INFO FOR OD EYE: (B)(4) 2006. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE LENSES REMAIN IMPLANTED IN THE PT AND ARE THEREFORE, NOT AVAILABLE FOR EVAL. (B)(4) 2006. (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN BOTH EYES. THE PT REPORTS EXPERIENCING HALOS IN THE LEFT EYE AND DIFFICULTY DRIVING AT NIGHT. THE PT ALSO REPORTS DETERIORATING VISION POSTOPERATIVELY; HOWEVER, ACCORDING TO THE PHYSICIAN'S RECORDS, THE PT'S CURRENT POSTOPERATIVE BCVA IS 20/20 IN BOTH EYES. THE PT HAS A (B)(6) HISTORY OF SEVERE CHRONIC BLEPHARITIS, SEVERE CHRONIC DRY EYE, AND MACULAR PUCKER. PRIOR TO RECEIVING THE CRYSTALENS, THE PT COMPLAINED OF BLURRY DISTANCE AND NEAR VISION AND INCREASED GLARE. THE PHYSICIAN BELIEVES THAT THE PT'S SYMPTOMS MAY BE CAUSED BY A COMBINATION OF THE FOLLOWING: REFRACTIVE ERROR; DRY EYES; AND POSTERIOR CAPSULAR OPACIFICATION. THE PT IS CURRENTLY BEING TREATED WITH BIFOCAL GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT45SE 002730

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other