BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7604379 · Received June 15, 2018

    Report

    Report Number
    2648035-2018-00875
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 14, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558281
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. (B)(4). DEVICE EVALUATION: IT WAS REPORTED THAT THE PRODUCT WAS NOT AVAILABLE SINCE IT WAS DISCARDED. THE COMPLAINT REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PCB00 DEVICE HAD A MAJOR COMPLICATION WITH A SHAVED OFF HAPTIC ON A PRELOADED LENS IN SURGERY. THE CUSTOMER ALSO NOTICED SOME INCONSISTENCIES WITH HOW THE LENS COMES OUT. THE CARTRIDGE AND THE LENS WERE IN CONTACT WITH THE PATIENT¿S LEFT EYE. THE LENS WAS PARTIALLY DELIVERED INTO THE PATIENT¿S EYE AND THEN REMOVED. REMOVAL AND REPLACEMENT OF THE LENS HAPPENED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS. THE PATIENT EXPERIENCED AN ANTERIOR CAPSULE TEAR, REQUIRING A VITRECTOMY. THE INCISION WAS ENLARGED AND A SUTURE WAS REQUIRED. THE PATIENT WAS REFERRED TO RETINA SPECIALIST FOR SECONDARY IOL IMPLANT AND VITRECTOMY. THE PATIENT WAS DOING WELL WHEN DISCHARGED. THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447306 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558281

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention