BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8512003 · Received April 13, 2019

    Report

    Report Number
    3011852734-2019-00090
    Event Type
    Injury
    Date Received
    April 13, 2019
    Date of Event
    March 12, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474534629
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE RETURNED TO MANUFACTURER ON: APR 08 2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS ONE HAPTIC COMPLETELY DETACHED AND STUCK TO THE OPTIC BODY. TRACES OF OVD (OPHTHALMIC VISCOSURGICAL DEVICE) ARE PRESENT WITH SIGNS OF MANIPULATION BY FORCEPS. THE LENS WAS CLEANED WITH PURIFIED WATER AND DRIED WITH COMPRESSED AIR TO EASE INSPECTION. FURTHER INSPECTION UNDER MAGNIFICATION DID NOT REVEAL ANY FURTHER DAMAGE. THE COMPLAINT EVENT IS CONFIRMED, HOWEVER AS PER THE CUSTOMER'S REPORT, THEY EXPERIENCED LOADING ISSUES THAT WERE DUE TO NEW TECHNICIAN'S ERRORS. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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.

    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

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. (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 THERE WAS A LENS LOADING ISSUE WITH A NEW TECHNICIAN. THE ZCB00 5.5 DIOPTER LENS WAS INSERTED AND A SEVERED HAPTIC WAS OBSERVED. THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT (OD) EYE REQUIRING INCISION ENLARGEMENT, AND REPLACED WITH A BACK UP LENS. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305406 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474534629

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention