BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TECNIS SIMPLICITY PRELOADED 1-PIECE IOL

    MDR report key: 10323364 · Received July 24, 2020

    Report

    Report Number
    2648035-2020-00551
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Report Date
    November 16, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474636
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WAS 2 INVESTIGATION COMPLETED DURING THIS PERIOD. BREAKDOWN OF 2 INVESTIGATION WITH RESPECTIVE SERIAL NUMBER IS AS FOLLOWS: 4975841911 COSMETIC ISSUES 5579741911 HAPTIC DETACHED, LENS DAMAGED THE INVESTIGATIONS CONCLUDED THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F AND G. 4 DATE 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 (B)(4) AND CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BREAKDOWN OF 2 EVENTS IS AS FOLLOWS: COSMETIC ISSUES 2. UDI NUMBER: A PARTIAL UDI NUMBER IS POPULATED FOR THIS MODEL AS FULL UDI FOR INTRAOCULAR LENS IS SPECIFIC TO DIOPTER. SERIAL NUMBER OF THE SUSPECT PRODUCT: (B)(4), 1. (B)(4), 1. ZERO INVESTIGATIONS HAVE BEEN COMPLETED AND 2 INVESTIGATIONS ARE PENDING FROM THIS PERIOD. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786850 TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. DCB00 05050474636

    Patients

    Seq Age Sex Outcome Treatment
    1