BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8825801 · Received July 25, 2019

    Report

    Report Number
    2648035-2019-00766
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    January 14, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474529038
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 08/07/2019. DEVICE EVALUATED BY MANUFACTURER. DEVICE EVALUATION: THE ZA9003 LENS WAS RETURNED IN ITS ORIGINAL PACKAGE. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE: LENS RETURNED CUT IN TWO PIECES. LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS PIECES RELATED THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. RESIDUES OF LUBRICANT MATERIAL WAS OBSERVED ON LENS PIECES. ONE OF THE HAPTIC WAS OBSERVED DISTORTED. THE OTHER HAPTIC WAS OBSERVED DETACHED. THE DETACHED HAPTIC PIECE WAS NOT RETURNED. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A LENS THAT WAS IMPLANTED AND REMOVED. THE COMPLAINT ISSUE REPORTED WAS VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED, THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT, OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT GENDER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. IF IMPLANTED, IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ZA9003 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT¿S OPERATIVE EYE WITH THE FRONT HAPTIC INTACT BUT THE REAR HAPTIC BROKE OFF AS THE LENS WAS FORWARDED. IT WAS REPORTED THE INCISION WAS ENLARGED, OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, AND NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622061 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZA9003 05050474529038

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention