BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM

    MDR report key: 23432687 · Received October 30, 2025

    Report

    Report Number
    3012236936-2025-000266
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 8, 2025
    Report Date
    January 6, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636088
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. . SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 09-OCT-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, A PHOTOGRAPH PROVIDED BY THE CUSTOMER WAS EVALUATED. THE PICTURE SHOWED A NOTCH/DENT LIKE MARK LOCATED IN THE LENS EDGE AT 10:00 IN RELATION WITH THE PICTURE ORIENTATION. PER THE ARK LOCATION, IT IS NOT EXPECTED TO HAVE CLINICAL IMPACT ON THE PATIENT'S VISUAL FUNCTION; HOWEVER, THE DEFINITIVE CLINICAL IMPACT AND THE POTENTIAL ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED FROM A PICTURE ASSESSMENT. 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 · 0

    IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON NOTED THE IOL HAD A DEFECT ON ONE EDGE. THROUGH FOLLOW UP, WE LEARNED THAT THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84193 TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown