BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1040024 · Received May 7, 2008

    Report

    Report Number
    2031924-2008-00192
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 5, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 LENS VAULTING WAS CAUSED BY CAPSULAR FIBROSIS WITH A LARGE ASYMMETRIC CAPSULOTOMY. IN ADDITION, THE STEROID DOSE PROVIDED TO THE PT WAS NOT EFFECTIVE ENOUGH TO PREVENT AGGRESSIVE HEALING RESPONSE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PT UNDERWENT CATARACT SURGERY WITH PLACEMENT THE CRYSTALENS IN HER RIGHT. ONE MONTH POSTOPERATIVELY THE LENS VAULTED ANTERIORLY, ALTHOUGH THIS DID NOT ADVERSELY AFFECT THE PT'S BCDVA. THE PHYSICIAN ATTRIBUTED THE EVENT TO CAPSULAR CONTRACTION SYNDROME. MULTIPLE YAG CAPSULOTOMIES WERE PERFORMED IN ORDER TO REPOSITION THE LENS. THE INTERVENTIONS WERE PERFORMED THREE DAYS IN 2008. IT IS IMPORTANT TO NOTE THAT PRIOR TO THESE INTERVENTIONS, THE PT'S BCVA WAS NOT WORSE THAN 20/20 AND MRSE WAS IMPROVED COMPARED TO BASELINE VALUE. CURRENTLY, THE LENS IS IN GOOD POSITION AND THE PT'S BCVA IS 20/20 OD. REFERENCE MDR # 2031924-2008-00133 FOR INFO ON THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 008964

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention