BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23318927 · Received October 16, 2025

    Report

    Report Number
    3012236936-2025-000268
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 13, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655485
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A - IMPLANT DATE: N/A, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED SECTION D6B - EXPLANT DATE: N/A, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED 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 THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: FOLLOWING A REVIEW OF THE ADDITIONAL INFORMATION PROVIDED, THE DETECTED MALFUNCTION HAS BEEN CLARIFIED: THE ISSUE WAS THAT THE LENS WAS STUCK IN THE CARTRIDGE. AS A RESULT, THE EVENT IS NO LONGER CONSIDERED REPORTABLE, AND NO FURTHER REPORTS WILL BE SUBMITTED UNDER REPORT NUMBER 3012236936-2025-0002689. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375691 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown