BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 5498775 · Received March 14, 2016

    Report

    Report Number
    2648035-2016-00380
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 16, 2016
    Report Date
    April 14, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION WAS INDICATED AS YES AND DATE RETURNED TO MANUFACTURER WAS COMPLETED WITH THE DATE OF 2/24/2016. HOWEVER AT A LATER DATE THIS WAS CLARIFIED THAT THE LENS ITSELF WAS NOT RECEIVED FOR EVALUATION. THIS FIELD HAS BEEN CORRECTED TO NOW REFLECT NO ¿ DEVICE NOT AVAILABLE FOR EVALUATION. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS IOL WAS NOT RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. MANUFACTURING RECORDS REVIEW: MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE UNITS WERE RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO OTHER COMPLAINTS WERE RECEIVED FOR THIS ORDER NUMBER TO DATE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDE INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTED CRACKED BEFORE LOADING IT INTO THE CARTRIDGE. NO PATIENT CONTACT WAS REPORTED AND A NEW IOL, SAME MODEL AND DIOPTER WAS LOADED AND IMPLANTED INSTEAD. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152912 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1