BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 2905482 · Received January 9, 2013

    Report

    Report Number
    2648035-2013-00005
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Removal / Correction Number
    2648035-01-03-13-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTRAOCULAR LENS. THE DEVICE WAS SENT TO THE MANUFACTURING SITE FOR EVALUATION SEALED AND WAS NOT USED. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WITH SERIAL NUMBER (B)(4) WAS RECEIVED IN THE FOLDING CARTON AND LENS CASE IN THE SEALED POUCHES. ALSO, THE DIRECTIONS FOR USE, PATIENT LENS IDENTIFICATION CARD, IMPLANT NOTIFICATION CARD, AND PATIENT LENS IMPLANT LABEL WERE RECEIVED. THE SERIAL NUMBER OF THE AFFECTED LENS BELONGS TO THE MANUFACTURING PRODUCTION ORDER, WHICH IS A 23.5 DIOPTER OF AR40E MODEL. THE SAMPLE WAS INSPECTED UNDER THE MICROSCOPE AT 10X MAGNIFICATION, WHICH IS THE NORMAL INSPECTION METHOD TOOL. NO COSMETIC DEFECTS WERE FOUND IN THE RETURNED LENS. A MANUFACTURING CERTIFIED OPERATOR INSPECTED THE LENS FOR OPTICAL PROPERTIES. OPTICAL INSPECTION RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDS TO A 23.5 DIOPTER LENS, WHICH INDICATES THAT THE LENS WAS WITHIN SPECIFICATION. CORRECTION: THE RECALL BOX HAS BEEN UNCHECKED. THIS INTRAOCULAR LENS IS NOT PART OF RECALL 2648035-01-03-13-R THAT WAS IDENTIFIED IN THE INITIAL MEDICAL DEVICE REPORT. THE CORRECTION/REMOVAL ACTION BOX IS BEING UNCHECKED. THERE IS NO CORRECTION/REMOVAL ACTION BEING PERFORMED FOR THIS INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN IS RETURNING A SEALED INTRAOCULAR LENS (IOL) THAT HAS NEVER BEEN USED DUE TO DIMINISHED CONFIDENCE OF THE LENS AND TO HAVE THE INTRAOCULAR LENS (IOL) TESTED FOR MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10661 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1