BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 7043612 · Received November 17, 2017

    Report

    Report Number
    9614546-2017-01125
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    September 21, 2017
    Report Date
    December 26, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474610200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION?: YES, RETURNED TO MANUFACTURER ON 11/06/2017. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS CUT IN HALF, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. 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 WERE 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.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZXR00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. ZXR00, WHICH FALLS UNDER PMA P980040. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXR00V 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. POST-OPERATIVELY, ONE DAY AFTER SURGERY, THE PATIENT COMPLAINED OF GLARE/PHOTOPHOBIA. THE DOCTOR PRESCRIBED SANPILO EYE DROPS FOR OCULAR HYPOTENSIVE EFFECT AND CONSTRICTED PUPIL, AS HE DOUBTED DYSPHOTOPSIA; HOWEVER, THE ISSUE WAS NOT RESOLVED. THEREFORE, THE LENS WAS EXPLANTED ON (B)(6) 2017, AND REPLACED WITH MODEL ZKB00. POST OP, A LITTLE DYSPHOTOPSIA AND A GRADUAL RECOVERY WERE REPORTED. NO ADDITIONAL MEDICINE WAS PRESCRIBED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821268 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00V 05050474610200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention