BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1220370 · Received November 4, 2008

    Report

    Report Number
    2031924-2008-00316
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    July 7, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BAUSCH & 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. 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 RIGHT EYE. APPROXIMATELY SIX MONTHS POSTOPERATIVELY, THE LENS VAULTED DUE TO CAPSULAR CONTRACTION SYNDROME. PREOPERATIVELY, THE PATIENT'S BCVA WAS 20/25 AND MRSE WAS +3.75 SPH. ONCE THE LENS VAULTED, THE MRSE CHANGED TO -1.00 -200 X 036. A YAG CAPSULOTOMY WAS PERFORMED TO REPOSITION THE LENS AND THE BCVA IMPROVED TO 20/25+2, J3, AND THE MRSE WAS PLANO SPH. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO CAPSULAR PHIMOSIS WHICH CAUSED THE SUPERIOR HAPTIC TO VAULT POSTERIORLY AND THE INFERIOR HAPTIC TO VAULT ANTERIORLY. THE PATIENT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL AT50SE 007096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention