BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8925900 · Received August 23, 2019

    Report

    Report Number
    9614546-2019-00769
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474552777
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 9/12/2019. SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: ON SEPTEMBER 12, 2019 THE RETURN SAMPLE WAS RECEIVED AND REVEALED THAT 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 RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FROM 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.

    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. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN (B)(6) 2019 AND (B)(6) 2019. (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 ZCT225 INTRAOCULAR LENS (IOL) 22.0 DIOPTER WAS EXPLANTED DUE TO POWER CHANGE. IT WAS REPLACED WITH A ZCT400, 21.0 DIOPTER POWER. IT WAS NOTED THAT THERE WAS NO INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY, PATIENT DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718116 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT225 05050474552777

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention