BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23917774 · Received December 29, 2025

    Report

    Report Number
    3012236936-2025-000342
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 29, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474743601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE SIMPLICITY TORIC II OPTIBLUE WITH TECNIS SIMPLICITY, MODEL DIW SERIES THAT HAS A SIMILAR DEVICE, TECNIS EYHANCETORIC II IOL WITH TECNIS SIMPLICITY MODEL DIU WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. 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 THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4581: DEVICE DECENTERED OR DISLOCATED OR TILTED SUBLUXATED OR WRONG POSITION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL), THE RESULT AIMED FOR WAS EMMETROPIA. THE CALCULATOR PREDICTED RESIDUAL ASTIGMATISM WAS -0.43D. THE ACCOUNT ALSO REPORTED THAT THE ASTIGMATISM DID NOT DECREASE THEREAFTER, SO THE IOL POSITION WAS ADJUSTED IN A SECONDARY OPERATION ON (B)(6) 2025. THE PATIENT WAS EXAMINED ON (B)(6) 2025 AND THE REFRACTION WAS S±0 C-1.75, WHICH IS NOT MARKEDLY DIFFERENT FROM THE PREOPERATIVE FINDINGS. PREOPERATIVE KERATOMETRY: K1 = 7.39, K2 = 7.00 @ 180°; ASTIGMATISM -2.75 D @ 90°. REFRACTION ON THE DAY AFTER SURGERY WAS S+1.00 C-3.50, REFRACTION TWO DAYS AFTER SURGERY WAS S+0.75 C-3.75 (NO AXIS SHIFT). THERE WERE NO PATIENT INJURIES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP WE LEARNED, THAT UNTIL THE IOL POSITION WAS ADJUSTED, THE IOL DIDN'T ROTATE, HOWEVER, IT APPEARED TO HAVE SHIFTED SLIGHTLY NASALLY. THE PLANNED AXIS ORIENTATION WAS 0 DEGREES. THE AXIS ORIENTATION AT IMPLANTATION: 0 DEGREES. THERE WERE NO UNEXPECTED SURGICAL PROCEDURES AND NO ADDITIONAL MEDICATIONS WERE PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917620 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIW450 05050474743601

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention