BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8761240 · Received July 3, 2019

    Report

    Report Number
    9614546-2019-00596
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    May 31, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605305
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 7/2/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION SHOWS THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS 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. 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.

    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 · 1

    (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 THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO A MYOPIC MISS. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT LOWER DIOPTER (24.0). THERE WAS NO OTHER INTERVENTION REQUIRED AND THE PATIENT WAS REPORTED TO BE DOING GOOD POST-EXCHANGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PREVIOUSLY HAD A RK (RADIAL KERATOTOMY) PROCEDURE WHICH MAY CAUSE THE HEALING PROCESS TO TAKE A LITTLE LONGER. THE PATIENT VISUAL ACUITY AFTER THE INITIAL IMPLANT POST-OP DAY ONE WAS 20/40, AND 20/25, J1 FOLLOWING THE EXCHANGE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552724 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474605305

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention