BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8186556 · Received December 20, 2018

    Report

    Report Number
    2648035-2018-01643
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558199
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 01/29/2019. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM, MODEL PCB00, WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. THE PLUNGER WAS OBSERVED IN ADVANCED POSITION. THE PLUNGER WAS GENTLY PULLED BACK AND FOUND LOCKED. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED NO TRACE OF VISCOELASTIC AND/OR BALANCED SALT SOLUTION IN THE CARTRIDGE. THE PCB00 CARTRIDGE WAS OBSERVED WITH STRESS MARKS AT THE TIP. THE DFU (DIRECTIONS FOR USE) STATES TO COMPLETELY FILL THE VIEWING WINDOW OF THE PCB00 WITH OVD (OPHTHALMIC VISCOSURGICAL DEVICE). THERE WERE NO DAMAGES OBSERVED. THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED THEREFORE AN EVALUATION WAS NOT POSSIBLE. THE CUSTOMER''S REPORTED ISSUE COULD NOT BE VERIFIED. NO PRODUCT QUALITY DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (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 AND 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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING 2018. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MODEL PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT, THE IOL WAS NOT USED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026502 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558199

    Patients

    Seq Age Sex Outcome Treatment
    1