BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8472076 · Received April 1, 2019

    Report

    Report Number
    2648035-2019-00409
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 4, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558274
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 04/04/2019. DEVICE EVALUATION: THE PRODUCT RETURN WAS RECEIVED ON 04/04/2019 IN A PLASTIC BAG. THE PLUNGER WAS OBSERVED IN ADVANCED POSITION. CARTRIDGE WAS OBSERVED CORRECTLY ENGAGED INTO LOWER BODY OF THE PCB00 DEVICE. NO ASSEMBLY DEFECTS WERE OBSERVED ON THE DEVICE. THE PCB00 DEVICE WAS OBSERVED UNDER MICROSCOPE AND A SCARCE AMOUNT OF VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE DIRECTIONS FOR USE (DFU) STATE TO COMPLETELY FILL THE VIEWING WINDOW OF THE PCB00 WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD). THE LENS WAS OBSERVED CUT. THE CONDITION OBSERVED IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. THE REPORTED ISSUE WAS NOT CONFIRMED. I,T COULD NOT BE DETERMINED IF THE CONDITION OBSERVED IS RELATED TO MANUFACTURING PROCESS AS THE REPORTED DEVICE WAS HANDLED AND PREPARED FOR A SURGICAL PROCEDURE. BASED ON THE PRODUCT RETURNED EVALUATION, A PRODUCT QUALITY DEFICIENCY NOR A PRODUCT MALFUNCTION COULD BE DETERMINED. 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 OTHER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED AND INJECTED INTO THE CAPSULAR BAG WITHOUT COMPLICATION. THE MALYUGIN RING WAS REMOVED FROM THE EYE. IRRIGATION AND ASPIRATION WAS THEN AGAIN PERFORMED TO REMOVE VISCOELASTIC MATERIAL. ON ROTATION OF THE LENS POSTERIOR CAPSULE, STRIA APPEARED AND THE CAPSULE ON EXAMINATION WAS SUSPECTED TO BE RUPTURED NASALLY. DISPERSIVE VISCOELASTIC WAS INSTILLED ABOVE AND BELOW THE LENS. THE MST (MICROSURGICAL TECHNOLOGY SCISSORS) WERE USED TO DIVIDE THE LENS INTO 3 PIECES AND REMOVE FROM THE EYE. 1% LIDOCAINE WAS INJECTED INTO THE SUB-CONJUNCTIVAL SPACE. THE WOUNDS WERE INVESTIGATED AND NO PROLAPSING VITREOUS WAS OBSERVED. A 3 PIECE LENS WAS INJECTED AFTER THE WOUND WAS ENLARGED AND POSITIONED INTO THE SULCUS WITH THE OPTIC CAPTURED IN THE ANTERIOR CAPSULOTOMY. TRIAMCINOLONE WAS INJECTED ANTERIOR TO THIS AND IRRIGATION REVEALED NO STAINING OF ANY VITREOUS, THIS WAS ASPIRATED FROM THE EYE, THE HYALOID FACE WAS THOUGHT TO BE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263420 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558274

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention