BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22173147 · Received June 9, 2025

    Report

    Report Number
    3012236936-2025-000161
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655447
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1: REPORTER 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 THE DEVICE HISTORY AND COMPLAINT TRENDING 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED ON 6/12/2025 STATED THAT THE CARTRIDGE TIP CRACK DOES NOT BELONG TO DIB00 LENS (SERIAL NUMBER: (B)(6)). HENCE THE DEVICE CODE "CARTRIDGE TIP CRACKED/DAMAGED" (1135) IS NO LONGER APPLICABLE TO DIB00 LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CRACKS WERE OBSERVED AT THE BOUNDARY OF THE OPTIC AND HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) POST-IMPLANTATION. HEALTHCARE PROFESSIONALS ADHERED TO THE LOADING GUIDELINES, AND NO ISSUES RELATED TO PERSONNEL, DELIVERY, OR STORAGE WERE REPORTED. THE IOL REMAINS IN THE PATIENT'S EYE, WITH NO REPORTED INJURY OR VISUAL COMPLICATIONS, AS THE CRACKS DID NOT AFFECT THE CENTRAL PART OF THE LENS. NO UNPLANNED VITRECTOMY REPORTED. ACCOUNT REPORTED CARTRIDGE TIP WAS SHARPER, ALTHOUGH NO DAMAGE WAS FOUND. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE NECESSARY, AND THE PATIENT IS RECOVERING WELL. FURTHER INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 6/12/2025 STATED THAT CARTRIDGE TIP CRACK DOES NOT BELONG TO DIB00 LENS (SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632500 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown