BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 6742613 · Received July 25, 2017

    Report

    Report Number
    9614546-2017-00665
    Event Type
    Injury
    Date Received
    July 25, 2017
    Report Date
    August 28, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474575707
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION LENS WAS EXPLANTED. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED TO THE MANUFACTURING SITE AS IT REMAINS IMPLANTED. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE 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.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A POST OPERATIVE MYOPIC OUTCOME FOLLOWING BILATERAL LENS IMPLANTS IN HIS PATIENT. PATIENT IS EXPERIENCING SOME DISCOMFORT IN THEIR VISION AND IS DISSATISFIED WITH THE RESULT. THROUGH FOLLOW UP, PATIENT PRE AND POST OPERATIVE INFORMATION WAS PROVIDED: PRE KERATOMETRY: OD (RIGHT EYE) 42.2(135°) X 42.6(45°); OS (LEFT EYE) 42.4(40°) X 43.0(130°); DIOPTER IMPLANTED: OD: 25.5 OS: 25.0. POST KERATOMETRY: OD 42.2(149°) X 43.0(59°) / OS 42.7(34°) X 43.0(124°). POST REFRACTION: OD: ESF:-2.25 CIL: -0.5(110°) / OS: ESF:-2.25 CIL: -1.0(70°) - 3 MONTHS AFTER THE SURGERY. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519881 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00 05050474575707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other