BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7887881 · Received September 18, 2018

    Report

    Report Number
    2648035-2018-01248
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 22, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION
    Product Code
    HQL
    UDI-DI
    05050474558106
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 10/9/2018. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. FIBER WAS SENT FOR FURTHER INVESTIGATION. FTIR ANALYSIS INDICATES THAT THE FOREIGN MATERIAL IS CONSISTENT WITH A CELLULOSIC MATERIAL (E.G. COTTON, RAYON, LINT). POTENTIAL AND INDIRECT EXPOSURE TO CELLULOSIC MATERIAL IS POSSIBLE; HOWEVER, THROUGHOUT THE MANUFACTURING PROCESSES THERE ARE VARIOUS CLEANING OPERATIONS AND 100% VISUAL INSPECTION UTILIZING A MICROSCOPE MAGNIFICATION STEPS THAT WOULD HAVE IDENTIFIED AND DISCARDED A LENS WITH A SIMILAR PARTICULATE, AS REQUIRED BY OUR APPROVED PROCEDURES. THE MANUFACTURING PROCESS IS PERFORMED INSIDE A REGULATED CLEAN ROOM CLASS 6 MANUFACTURING ROOM THAT REQUIRES FULL GOWNING BEFORE ENTERING THE ROOM. THE MANUFACTURING DATA CONFIRMED THAT NO PROCESS DEVIATION COULD BE UNDETECTED BY OUR CONTROL PROCESS. THE COMPLAINT ISSUE REPORTED WAS VERIFIED. IT, HOWEVER, COULD NOT BE FULLY CONFIRMED IF THE PARTICLE IDENTIFIED WAS FROM THE MANUFACTURING PROCESS, SINCE THE DEVICE WAS HANDLED AND PREPARE FOR SURGICAL PROCESS. BASED ON THE ANALYSIS OF THE RETURN, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO SIMILAR INVESTIGATIONS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED IN PATIENT EYE; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT WAS NOTED TO HAVE AN UNIDENTIFIABLE FOREIGN OBJECT ATTACHED TO THE UNDERSIDE OF THE LENS. THE FOREIGN OBJECT WAS REMOVED AND RETAINED. THERE WAS NO INJURY TO PATIENT. THE PATIENT IS DOING FINE POSTOP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726663 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION PCB00 05050474558106

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR