BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 9537268 · Received January 2, 2020

    Report

    Report Number
    9614546-2020-00001
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    October 19, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605817
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT225 INTRAOCULAR LENS (IOL) 21.0 DIOPTER WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING GLARE - VISUAL ISSUES. THRU FOLLOW-UP IT WAS ALSO REPORTED DESPITE VASC (VISUAL ACUITY SANS CORRECTION) 20/25 WITH MINIMAL RX (PRESCRIPTION), PATIENT COMPLAINED OF BLURRED VISION AND LACK OF CLARITY. PATIENT DID NOT TOLERATE GLARE WITH SPIDERWEBBING WHEN DRIVING AT NIGHT. A MONOFOCAL PLACED. GLASSES AND MAXIMIZING THE OCULAR SURFACE WERE TRIED. PATIENT WAS NEVER HAPPY WITH VISION AND SPIDERWEB/GLARE AROUND LIGHTS. VISUAL ISSUES WERE FIRST NOTED ONE-DAY POST-OP. THE CUSTOMER FURTHER CLARIFIED THE REASON FOR THE EXPLANT WAS DEFRACTIVE LENS INTOLERANCE-HALOS. A PARS PLANA VITRECTOMY WAS REQUIRED, AND THE IOL WAS REPLACED WITH A DIFFERENT IOL MODEL, ZCT150 21.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225 05050474605817

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention