BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 2640447 · Received June 26, 2012

    Report

    Report Number
    9611165-2012-00031
    Event Type
    Other
    Date Received
    June 26, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA. HOWEVER, THE SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS HAPTICS ARE THE SAME DESIGN AS THE HAPTICS ON THE C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES. THE C-FLEX 570C AND C-FLEX ASPHERIC 970C ARE AVAILABLE IN THE UNITED STATES OF AMERICA. A CORRECTIVE ACTION WAS TAKEN BY THE PHYSICIAN AND A BACK-UP SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS WAS IMPLANTED WITHIN THE INITIAL SURGERY SESSION. THE HEALTHCARE FACILITY HAS INFORMED RAYNER THAT THEY WILL BE CONDUCTING A POST-OPERATIVE CONSULTATION ONE WEEK AFTER THE IMPLANTATION OF THE DEVICE. THE INFO PROVIDED BY THE HEALTHCARE FACILITY INDICATES THAT THE HAPTIC BREAKAGE MAY HAVE OCCURRED AS A RESULT OF A USER ERROR. THERE IS NO INDICATION THAT THIS EVENT OCCURRED AS A RESULT OF A DEVICE DEFECT OR MALFUNCTION. OUR REVIEW OF PRODUCTION RECORDS OF THE SUPERLFEX ASPHERIC 920H BATCH (B)(4) CONFIRMS THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FROM THIS BATCH WERE WITHIN TOLERANCE LIMITS AND SPEC. NO COMPLAINTS OF ANY TYPE HAVE BEEN RECEIVED AGAINST THE SUPERFLEX ASPHERIC 920H BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED A NOTIFICATION FROM THE (B)(6) HOSPITAL OF AN ADVERSE EVENT THAT OCCURRED DURING THE USE OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS. THE EVENT DESCRIPTION IS AS FOLLOWS "ON INSERTING THE LENS THE HAPTIC BROKE AT THE NON-LEADING EDGE. THIS WAS REMOVED AND REPLACED WITH ANOTHER LENS. THE HAPTIC BREAKAGE RECURRED. THESE LENSES REQUIRED REMOVAL AND CAUSED SOME MINOR IRIS TRAUMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 920H 012E31352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention