BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8299567 · Received February 1, 2019

    Report

    Report Number
    2648035-2019-00149
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 10, 2019
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED (B)(6). PMA/510(K): THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT REMAINS IMPLANTED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FILAMENTARY FOREIGN MATERIAL WAS SEEN TOUCHING THE IRIS DURING A SLIT LAMP EXAM THE DAY AFTER IMPLANTATION OF A PCB00V 20.0 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2019. THE COLOR OF THE FILAMENT LOOKED BROWN OR WHITE AND THERE WAS SOME INFLAMMATION FOUND ON THE IRIS OF THE OPERATIVE EYE. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT INJURY. ALSO, THROUGH ADDITIONAL FOLLOW UP, IT WAS REPORTED THAT THERE IS STILL FOREIGN MATERIAL ON THE IRIS AND INFLAMMATION IS NO LONGER PRESENT. THE PATIENT WILL CONTINUE TO BE OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91773 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other