BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 8903907 · Received August 16, 2019

    Report

    Report Number
    2648035-2019-00898
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 26, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474546752
    Adverse Event
    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

    EXPLANT DATE: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR 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 ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THE INTRAOCULAR LENS REMAINS IMPLANTED IN THE PATIENT EYE. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN THE COMPLAINT SYSTEM REVEALED THAT THERE WAS NO ADDITIONAL INVESTIGATION REQUEST FOR THIS PRODUCTION ORDER NUMBER. 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 THE INTRAOCULAR LENS, MODEL ZCB00V, 20.5 DIOPTER WAS IMPLANTED ON (B)(6) 2019. THE PATIENT'S PREOPERATIVE VISUAL ACUITY (VA) WAS 0.1 AND IT WAS 0.7 THE DAY AFTER THE SURGERY. THE VISUAL ACUITY BECAME 0.4 ON THE 10TH POSTOPERATIVE DAY, AND HYPEREMIA AND FIBRIN WERE OBSERVED. AN ANTIMICROBIAL AGENT WAS USED AND THE HYPEREMIA SUBSIDED. MEDICATIONS USED WERE BIOMYCIN INSTILLATION AND CEPHEM. SLIT FINDINGS SHOWED THERE WAS FIBRIN FROM THE BACK OF THE IRIS TO THE CENTER OF THE PUPIL. THERE WAS ADHESION TO THE IRIS, BUT WHAT HAD SPREAD THROUGHOUT HAD DISAPPEARED BY ABOUT HALF. HOWEVER, DOCTOR WAS CONCERNED ABOUT THE 0.3 VISUAL ACUITY CHANGE IN PATIENT'S SIGHT. THE PATIENT REPORTED SEEING SOMETHING LIKE FOG. PATIENT'S COMPANION EYE SURGERY WAS POSTPONED. DURING CONJUNCTIVAL CULTURE EXAMINATION, FLARE VALUE WAS REPORTED TO BE 26. THE DOCTOR IS CONVINCED THAT THE ISSUE DID NOT ORIGINATE FROM THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695067 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00V 05050474546752

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention