BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 6437900 · Received March 27, 2017

    Report

    Report Number
    2648035-2017-00572
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    February 27, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474552104
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO/CORRECTED DATA: IN REVIEW OF THE FILE, IT WAS FOUND THAT THIS EVENT REPORTED IS A DUPLICATE OF PREVIOUSLY REPORTED EVENT, UNDER COMPLAINT (B)(4), AND MANUFACTURING REPORT NUMBER: 9614546-2017-00221. THEREFORE, NO FURTHER INFORMATION WILL BE SUBMITTED UNDER THIS FILE. ALL PERTINENT INFORMATION WAS SUBMITTED UNDER COMPLAINT (B)(4) AND MANUFACTURING REPORT NUMBER 9614546-2017-00221. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT IMPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LATHE MARKS ON THE OPTIC AREA. THE EVENT WAS NOTICED DURING HANDLING BUT PRIOR TO INSERTION. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217540 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT150 05050474552104

    Patients

    Seq Age Sex Outcome Treatment
    1