BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8630149 · Received May 21, 2019

    Report

    Report Number
    3011852734-2019-00110
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    March 21, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560062
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION RECEIVED AND IT WAS LEARNED THAT THE INCISION WAS ENLARGED VERY SLIGHTLY DURING THE EXPLANT. THE CUSTOMER COULD NOT REMEMBER IF A STITCH/SUTURE WAS USED. ALSO, IT WAS LEARNT THAT THE PATIENT WAS 20/30 UNCORRECTED (UC), J2 AT ONE WEEK POST OP. AT FOUR WEEKS POST-EXCHANGE, THE PATIENT IS HAPPY AND HAS HAD NO ISSUES WITH THE COMPUTER OR DASHBOARD WITH THE NEWLY IMPLANTED MODEL ZKB00 LENS. PLAN IS TO USE A MODEL ZLBOO FOR THE SECOND EYE TO ACHIEVE BETTER NEAR READING VISION. PATIENT CODE 3191: INCISION ENLARGEMENT. DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 6/12/2019. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE RETURNED SAMPLE WAS RECEIVED WITHIN ITS REPLACEMENT LENS¿ DAISY WHEEL KEPT INSIDE OF A PLASTIC JAR. A VISUAL INSPECTION OF THE LENS SHOWED TRACE OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AS WELL AS A SCRATCH ACROSS THE OPTIC SURFACE. THE LENS WAS CLEANED WITH PURIFIED WATER AND DRIED WITH COMPRESSED AIR TO EASE INSPECTION. FURTHER INSPECTION UNDER MAGNIFICATION SHOWS A SMALL CUT ON THE LENS, MOST PROBABLY MADE TO AID IN EXPLANT. THE REPORTED ISSUE COULD NOT 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 OTHER 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 CONFIRMED. 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

    (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 ZKB00, 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT RIGHT EYE. POST-OPERATIVELY, THE RESULTS WERE NOT AS INTENDED. THE PATIENT COMPLAINED OF BLURRED VISION AND COULD NOT READ. THERE WERE NO INJURIES AND NO ADDITIONAL INTERVENTION WAS PERFORMED. AT THE 1-MONTH POST-OP VISIT, THE PATIENT WAS 20/40-1 UNCORRECTED VISUAL ACUITY (UCVA); +1.00+0.25X35 MANIFEST REFRACTION, +0.75+0.50X39 AUTO REFRACTION. UNCORRECTED VISION NEAR (UCVN) WAS J10 @ 16 INCHES. BEST CORRECTED FINAL VISUAL ACUITY (VA) WAS 20/25; FINAL NEAR VA WAS J1-1 @ 16 INCHES, DISTANCE 20/25. IT WAS REPORTED THERE WAS NO MALFUNCTION WITH THE IOL. THE SURGEON THEN PERFORMED AN IOL EXCHANGE TO A ZKB00, 21.0 DIOPTER SIZE. NO REPORT OF INCISION ENLARGEMENT, VITRECTOMY AND SUTURES DONE. NO PATIENT POST-OP INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422804 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZKB00 05050474560062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention