BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7528026 · Received May 18, 2018

    Report

    Report Number
    2648035-2018-00732
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 19, 2018
    Report Date
    August 6, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558519
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM (MODEL PCB00) WAS NOT RETURNED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE "CUSTOMER'S" REPORTED COMPLAINT COULD NOT BE VERIFIED. 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 ADDITIONAL 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

    CORRECTED DATA: THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NUMBER ONE (1) FOR MANUFACTURER REPORT NUMBER 2648035-2018-00732. IN REVIEW, WHAT SHOULD HAVE BEEN FOLLOW-UP #1 WAS INADVERTENTLY SUBMITTED WITH THE NUMBER TWO (2) POPULATED IN SECTION G6 TYPE OF REPORT FOLLOW-UP #. 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 NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT THE CARTRIDGE TIP WAS DAMAGED. THE IOL WAS NOT IMPLANTED. THE IOL WAS NOT USED NOR DID IT COME IN CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368324 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown