BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23872123 · Received December 22, 2025

    Report

    Report Number
    3012236936-2025-000340
    Event Type
    Injury
    Date Received
    December 22, 2025
    Report Date
    January 17, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474635852
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE LENS WAS PLACED IN THE PATIENT'S CAPSULAR BAG WITHOUT COMPLICATION BUT THE SURGEON NOTED THAT THE BAG WAS NOT STABLE. THE SURGEON CHOSE TO REMOVE THE LENS DURING THE SAME PROCEDURE TO PREVENT FURTHER COMPLICATION AND THE PATIENT WAS LEFT APHAKIC, WITH NO REPLACEMENT LENS PLACED. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY AND NO UNPLANNED SURGICAL INTERVENTIONS OR MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. IT WAS NOTED THAT THE CATARACT EXTRACTION WAS SCHEDULED WITH A PARS PLANA VITRECTOMY AND THE SURGEON ALWAYS USES SUTURES. THE PATIENT TOLERATED THE SURGERY WELL, AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. THERE ARE NO PLANNED SURGICAL INTERVENTIONS. IT WAS REPORTED THAT THE LENS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT, AS THE ISSUE WAS THAT THE PATIENT'S CAPSULE WAS NOT STABLE. NO FURTHER INFORMATION WAS PROVIDED. CORRECTED DATA: BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S EYE DUE TO AN INSTABILITY OF THE PATIENT'S CAPSULAR BAG, WITH NO PATIENT INJURY, AND IT WAS CONFIRMED THAT THE ISSUE WAS NOT DUE TO THE DEVICE. THERE IS NO QUALITY ISSUE WITH JOHNSON & JOHNSON IOL. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THE HEALTH EFFECT - CLINICAL CODE OF 1845 (EYE INJURY) THAT WAS ORIGINALLY REPORTED ON THE INITIAL MDR NO LONGER APPLIES. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2025-0003407. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED; 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 WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION 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) WAS IMPLANTED AND LATER REMOVED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PRODUCT WAS DISCARDED; THEREFORE, NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745755 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474635852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention