BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 6351973 · Received February 23, 2017

    Report

    Report Number
    2648035-2017-00353
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 24, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE SERIAL NUMBER IS UNKNOWN, THEREFORE THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS COULD NOT BE REVIEWED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS REMAINED IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER PCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. PCB00, WHICH FALLS UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JUST AFTER THE INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE SURGEON OBSERVED A CRACK IN THE OPTIC PART. REPORTEDLY, THE LENS REMAINED IMPLANTED IN THE PATIENT'S EYE. THE VISUAL ACUITY WAS 1.2D (20/16). NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135863 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1