BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8402253 · Received March 7, 2019

    Report

    Report Number
    2648035-2019-00296
    Event Type
    Injury
    Date Received
    March 7, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558182
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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 A SECOND ATTEMPT TO IMPLANT AN INTRAOCULAR LENS WAS UNSUCCESSFUL LIKE THE FIRST AND THE HAPTIC OF AN INTRAOCULAR LENS BECAME DETACHED AND INVOLVED PATIENT CONTACT. THE LENS WAS CUT OUT OF THE EYE, A VITRECTOMY WAS PERFORMED AGAIN, AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS TRIED, BUT UNSUCCESSFUL AGAIN HAVING THE SAME HAPTIC DETACHED ISSUE. THEREFORE, THE DOCTOR CHANGED THE MODEL TO A ZCB00 AND IMPLANTED THAT SUCCESSFULLY. REPORTEDLY, THE PATIENT DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE SECOND OF TWO INTRAOCULAR LENS USED ON THE SAME PATIENT. A SEPARATE REPORT WILL CAPTURE THE FIRST INTRAOCULAR LENS USED ON THE PATIENT. AFTER BOTH THESE INTRAOCULAR LENSES WERE TRIED, A THIRD ATTEMPT WAS TRIED WITH MODEL ZCB00 AND HAD NO ISSUES OR COMPLICATIONS. (JN (B)(6) 2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194821 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention