BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 8553670 · Received April 26, 2019

    Report

    Report Number
    9614546-2019-00367
    Event Type
    Injury
    Date Received
    April 26, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS EARLY 2019. CATALOG NUMBER: A COMPLETE CATALOG# IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UNIQUE DEVICE IDENTIFIER (UDI #): UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS SYMFONY OPTIBLUE INTRAOCULAR LENS, MODEL ZXV375 THAT HAS A SIMILAR DEVICE, TECNIS SYMFONY IOL MODEL ZXT375 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT REMAINS IMPLANTED AND IT WAS NOT RETURNED. THE CUSTOMER'S REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORD REVIEW: A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AS NO SERIAL NUMBER WAS PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS MODEL, ZXV375 ROTATED POST-OPERATION, LEADING TO AN INCREASE IN ASTIGMATISM MORE THAN BEFORE THE SURGERY(REFERENCE:-5.75D, 16 DEGREES, KERATO: -2.5D, 15 DEGREES). IT WAS INDICATED THAT THE INPUT TO THE CALCULATOR WAS CORRECT AND THE AXIS ALIGNMENT WAS DONE WITH VERION, SO ASTIGMATISM INCREASED WITH ROTATION AFTER THE SURGERY. AXIS CORRECTION SURGERY (LENS REPOSITION) WAS PERFORMED ON (B)(6) 2019 WHICH AFTER THAT OPERATION THE VISUAL ACUITY WAS 0.7 AND PATIENT FELT GOOD (REDUCED TO 0.5D WITH TOTAL ASTIGMATISM). REPORTEDLY, UNAIDED DISTANCE VISION IS 0.4. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348236 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXV375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention