BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9344763 · Received November 19, 2019

    Report

    Report Number
    2648035-2019-01223
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558298
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 · 0

    DEVICE EVALUATION: A THIN PARTICLE WAS RECEIVED SECURED TO A FABRIC STRIP WITH ADHESIVE TAPE. NO DEVICE WAS RECEIVED. ACCORDING TO THE PARTICLE RECEIVED THE COMPLAINT WAS VERIFIED. THE PARTICLE SECURED TO THE FABRIC STRIP WAS SENT TO EAG LABS FOR ANALYSIS. BASED ON THE MANUFACTURING RECORDS REVIEW, ANALYSIS OF THE RETURN, EAG LABS RESULTS AND COMPLAINT OCCURRENCES REVIEW THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS NOT REMOVED OR REPLACED DURING THE SURGERY. THE PATIENT WAS FINE AT DISCHARGE AND CONTINUES TO BE FINE. THEIR VISION HAS NOT BEEN AFFECTED BY THIS INCIDENCE. IT WAS CONFIRMED THAT THE DEBRIS PIECE IS AVAILABLE, BUT THE INJECTOR IS NOT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF INJECTING THE INTRAOCULAR LENS (IOL), MODEL PCB00 21.5 DIOPTER INTO THE EYE, A WHITE OPAQUE FOREIGN BODY WAS NOTED CAUGHT BETWEEN THE HAPTIC AND THE OPTIC. IT WAS WITHIN THE INJECTOR SYSTEM SO THE DOCTOR IS CONVINCED THIS WAS INJECTED INTO THE EYE FROM THE PCB00 DEVICE. THE SURGEON IMMEDIATELY REMOVED THE MATERIAL WHICH IS HARD AND LOOKS LIKE PLASTIC. THE MATERIAL IS AVAILABLE. NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136203 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558298

    Patients

    Seq Age Sex Outcome Treatment
    1