BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7485719 · Received May 3, 2018

    Report

    Report Number
    2648035-2018-00663
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 3, 2018
    Report Date
    June 25, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558366
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT FULLY IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT FULLY IMPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 5/8/2018. DEVICE EVALUATION: THE PCB00 INSERTION DEVICE WITHOUT THE LENS WAS RECEIVED INSIDE THE ORIGINAL BOX. THE PLUNGER WAS OBSERVED IN ADVANCED POSITION. THE PLUNGER WAS GENTLY PULLED BACK AND FOUND LOCKED. THE PCB00 DEVICE WAS OBSERVED UNDER MICROSCOPE AND TRACES OF VISCOELASTIC AND/OR BALANCED SALT SOLUTION WERE OBSERVED AT THE CARTRIDGE TIP. THE PCB00 CARTRIDGE WAS OBSERVED WITH STRESS MARKS AT THE TIP. DIRECTION FOR USE (DFU) STATES TO COMPLETELY FILL THE VIEWING WINDOW OF THE PCB00 WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD). A LENS DETACHED HAPTIC WAS FOUND STUCK AT THE CARTRIDGE TIP. 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 ISSUE WAS NOT VERIFIED. NO PRODUCT QUALITY DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE RIGHT EYE. THE CARTRIDGE AND LENS WERE IN CONTACT WITH THE PATIENT¿S EYE. THE LENS WAS PARTIALLY DELIVERED INTO THE EYE, REMOVED AND REPLACED. THERE WAS NO VITRECTOMY. INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326163 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558366

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR