BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21690508 · Received March 25, 2025

    Report

    Report Number
    3012236936-2025-000077
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 24, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810747
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW THE MEDICAL DEVICE PROBLEM CODE DC-DIFFICULT TO USE-1487 IS ADDED. HENCE A CORRECTION REPORT WOULD BE SUBMITTED FOR US WITH AWARE DATE BEING 4/17/2025, THE DATE OF REASSESSMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4 AND A5: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED IN THE EYE. SECTION H6 - HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (INCISION ENLARGEMENT). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION (LENS REMAINS IMPLANTED). THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND NO PRODUCT QUALITY DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE FOUND. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT THE INSERTER OF THE PRELOADED INTRAOCULAR LENS (IOL) COULD NOT FIT THROUGH THE 2.4 INCISION IN THE RIGHT EYE OF THE PATIENT. THE INCISION WAS ENLARGED AND IOL WAS IMPLANTED. HOWEVER, THE LENS WAS FOUND TO BE SCRATCHED. THE PATIENT IS FINE AND THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE; THERE ARE NO PLANS TO EXPLANT THE DEVICE. THERE WERE NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093687 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810747

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female