BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22475730 · Received July 10, 2025

    Report

    Report Number
    3012236936-2025-000191
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 22, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655362
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT WITH THE DEVICE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. SECTION E1: PHONE NUMBER: (B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO VISIBLE DAMAGE WAS FOUND UPON OPENING THE BOX OR THE POUCH. CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTICED THAT IT WAS THE IMPLANT THAT WAS OUT OF THE CARTRIDGE WHILE OPENING THE BOX AND NOT THE WHOLE DEVICE OUT OF THE PACKAGING. AS THE REPORTED EVENT DOES NOT MEET THE LOCAL REGULATION FOR REPORTABILITY, THE EVENT IS NO LONGER REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 3012236936-2025-0001910. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS HALF OUT OF THE PACKAGING. THERE WAS NO PATIENT'S CONTACT. THE ISSUE OBSERVED WHEN OPENING THE BOX. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820616 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown