BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4757605 · Received May 7, 2015

    Report

    Report Number
    1119421-2015-05271
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Report Date
    August 25, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A COMPANY PHYSICIAN OF THE MANUFACTURER EVALUATED FOUR PHOTOS THAT WERE PROVIDED. THE FIRST IMAGE, A PHOTO LABELED AS ¿OS ¿ AFTER 21 DAYS¿, THE FIRST IMAGE IS A FUNDUS PHOTO WHICH DOES NOT APPEAR TO SHOW ABNORMAL FINDINGS. MILD WHITENING ON ANTERIOR CAPSULE REMNANT MAY BE OBSERVED INTO PHOTOS 2 & 3. MULTIPLE LIGHT SCATTERING ARTIFACTS/APPARENTLY MICRO VACUOLES CAN BE OBSERVED IN PHOTO 4, AND APPEAR TO BE LOCATED IN THE IOL BODY. THE MICRO VACUOLES ARE OF VARIABLE DIAMETER, WHICH CANNOT BE DETERMINED ACCURATELY BASED ON THE IMAGE; HOWEVER, IT SEEMS TO BE APPROXIMATELY =0.1MM. THE OBSERVED LIGHT SCATTERING ARTIFACTS ARE COMPATIBLE WITH GLISTENINGS. THE ANTERIOR CAPSULE REMNANT WHITENING FINDINGS ARE COMPATIBLE WITH ANTERIOR CAPSULE OPACIFICATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, GLISTENING OR BLOOD CELLS WERE OBSERVED ON THE SURFACE OF THE LENS. BLOOD DRAWING WAS DONE AND NO PROBLEM WAS FOUND WITH NORMAL SOLIDIFICATION FUNCTION INCLUDING ANTITHROMBIN III (AT3). WHITE BLOOD CELL (WBC) LOW VALUE OF 2910, RED BLOOD CELL (RBC) SLIGHTLY BELOW VALUE OF 4260000. ORDERING OF PROTEIN FRACTION, PROTEIN C, S, ANTINUCLEAR ANTIBODY, ANTICARDIOLIPIN ARE IN PROGRESS WITH OUTSIDE SUPPLIER. IT MIGHT BE SOME BLOOD DISEASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300166 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other MONARCH III D CARTRIDGES