BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8701230 · Received June 14, 2019

    Report

    Report Number
    2648035-2019-00643
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605336
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 7/1/2019. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE LENS IS CUT IN TWO PIECES; THIS IS MOST PROBABLY RELATED TO THE EXPLANT PROCESS DESCRIBED IN THE INITIAL REPORT. DUE TO THE CONDITIONS OF THE LENS FURTHER EVALUATION IS NOT POSSIBLE. THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED AN ADDITIONAL INVESTIGATION REQUEST (IR) FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED, HOWEVER THE REPORTED DEVICE PROBLEM CODE IS UNRELATED TO THIS COMPLAINT. 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 · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2018 AND (B)(6) 2019. (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZXT150 INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENT'S LEFT EYE WAS EXCHANGED DUE TO PATIENT COMPLAINT OF HALOS AND GLARE. THE EXPLANTED IOL WAS REPLACED WITH A ZCT150 IOL. IT WAS REPORTED THAT AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED DURING THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED. VA PRE-OP: 20/30 BEFORE GLARE; 20/70 WITH GLARE. VA POST-OP: 20/20 +.25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493631 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474605336

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention