BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23156906 · Received September 26, 2025

    Report

    Report Number
    3012236936-2025-000252
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 28, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: FURTHER INFORMATION WAS PROVIDED AND REPORTED TIP OF THE CARTRIDGE CRACKED WAS NOTICED PRIOR TO PATIENT CONTACT. IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT. THE SURGEON REALIZED THE TIP OF THE CARTRIDGE WAS CRACKED AS THE PISTON WAS PUSHED FORWARD. THE SURGEON INSPECTED THE CARTRIDGE UNDER THE MICROSCOPE AND DECIDED NOT TO MOVE FORWARD WITH THIS LENS AND USED A BACK-UP LENS INSTEAD. THEREFORE, THE EVENT IS NO LONGER REPORTABLE FOR THE CARTRIDGE TIP CRACKED/DAMAGED AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER REPORT NUMBER 3012236936-2025-0002528. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE LENS HAS BEEN EXPLANTED. SECTION E1: FIRST/GIVEN NAME: UNKNOWN/NOT PROVIDED. 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 THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A CRACK AT ITS TIP. CONSEQUENTLY, A BACKUP LENS WAS UTILIZED TO CONTINUE THE PROCEDURE FOR PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059326 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown