BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1220454 · Received November 4, 2008

    Report

    Report Number
    2031924-2008-00317
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BAUSH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. CONCLUSIONS - ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE REPORTED PROBLEM OF LENS VAULTING WAS RELATED TO CAPSULAR CONTRACTION SYNDROME.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PATIENT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CYSTALENS IN THE LEFT EYE. APPROXIMATELY ONE MONTH POSTOPERATIVELY, THE LENS VAULTED DUE TO CAPSULAR CONTRACTION SYNDROME. PREOPERATIVELY, THE PATIENT'S BCVA WAS 20/20 AND MRSE WAS +0.50 SPH. AFTER THE LENS VAULTED, THE BCVA DECREASED TO 20/80. THE LENS WAS REPOSITIONED IN 2008, AND THE FOLLOWING DAY A YAG CAPSULOTOMY WAS PERFORMED. AFTER THE INTERVENTIONS, THE BCVA IMPROVED TO 20/30 AND THE MRSE WAS +1.25 +0.50 X 047. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO TEMPORAL CAPSULAR PHIMOSIS WHICH CAUSED THE LENS TO VAULT POSTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSH & LOMB SURGICAL AT50SE 012491

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention