BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7482155 · Received May 2, 2018

    Report

    Report Number
    2648035-2018-00644
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 3, 2018
    Report Date
    June 25, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558298
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 5/8/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PCB00 INSERTION DEVICE WAS RECEIVED WITHOUT THE LENS INSIDE THE ORIGINAL BOX. THE PLUNGER WAS OBSERVED IN FULLY ADVANCED POSITION. THE PCB00 DEVICE WAS OBSERVED UNDER MICROSCOPE AND TRACES OF VISCOELASTIC AND/OR BALANCED SALT SOLUTION WERE OBSERVED IN THE CARTRIDGE. DFU STATES TO COMPLETELY FILL THE VIEWING WINDOW OF THE PCB00 WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD). NO LENS OR PORTION OF THE LENS WAS OBSERVED INSIDE THE PCB00 DEVICE; THE LENS WAS NOT RETURNED. THE PCB00 CARTRIDGE WAS OBSERVED WITH STRESS MARKS AT THE TIP. THE PCB00 DEVICE WAS OPENED AND NO ASSEMBLY DEFECTS WERE OBSERVED. THERE WERE NO DAMAGES OBSERVED ON THE ASSEMBLY, NEITHER FLASHES (SCREW THREAD AND NUT THREAD WERE FOUND WITHOUT DAMAGES). THERE IS NO VISIBLE GAP. THE REPORTED COMPLAINT ISSUE WAS NOT VERIFIED. NO PRODUCT QUALITY DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED NO ADDITIONAL INVESTIGATIONS REQUESTED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DFU WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING AN ISSUE WITH PCB00 PRELOADED DEVICE. THERE WAS A PLUNGER ROD AND LENS STUCK IN THE INSERTER/CARTRIDGE ISSUE. THE INTRAOCULAR LENS (IOL) WAS PARTIALLY DELIVERED INTO THE PATIENT'S LEFT EYE (OS). THE IOL WAS THEN REMOVED AND REPLACED SUCCESSFULLY WITH A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WERE NO COMPLICATIONS NOTED AT THE TIME OF PATIENT DISCHARGE. THE REMOVED LENS WAS NOTED TO BE LOST IN THE DRAPING AND WAS UNABLE TO BE FOUND BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324042 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558298

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR