BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 7637015 · Received June 26, 2018

    Report

    Report Number
    9614546-2018-00607
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    November 29, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474614888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE INITIAL MDR 9614546-2018-00607, IT WAS INCORRECTLY REPORTED THAT THE DEVICE WAS RETURNED ON 06/18/2018. THE DEVICE WAS RETURNED ON 06/15/2018 INSTEAD. THEREFORE DEVICE AVAILABLE FOR EVALUATION SECTION WAS UPDATED ACCORDINGLY. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 12X MICROSCOPE MAGNIFICATION SHOWED THAT THE PRODUCT WAS DAMAGED, MOST PROBABLY TO MAKE THE EXPLANT POSSIBLE. INVESTIGATION OF THE RETURN SAMPLE DO NOT SUGGEST THAT THE DAMAGE WAS INTRODUCED DURING MANUFACTURING. 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. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. 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 JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; ZXV150 THAT HAS SIMILAR DEVICESWHICH ARE DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040 (ZXT150, ZXT225, ZXT300, ZXT375). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZXV150 +8.5 DIOPTER INTRAOCULAR LENS (IOL) WAS TILTED AFTER IMPLANTATION AS THE POSTERIOR CAPSULE WAS BROKEN. SINCE THE PATIENT MENTIONED THAT IT WAS DIFFICULT TO SEE, THE IOL WAS EXPLANTED AND REPLACED WITH AN IOL OF A DIFFERENT MODEL (ZMA00 UNKNOWN DIOPTER SIZE) DURING A SECONDARY SURGICAL PROCEDURE. IT WAS REPORTED THAT THE CAPSULE BROKE BEFORE THE IOL INSERTION. THERE WAS NO VITRECTOMY OR ANY OTHER MEDICAL/SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480359 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXV150 05050474614888

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention