BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23764703 · Received December 9, 2025

    Report

    Report Number
    3012236936-2025-000309
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    October 14, 2024
    Report Date
    December 10, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531697
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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 THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    DURING A CLINICAL STUDY, IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT AND LEFT EYE. DURING A POST-OPERATIVE EXAMINATION FOR BOTH EYES POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED. REPORTEDLY THE DIRECTIONS FOR USE WERE FOLLOWED. THE SYMPTOMS WERE NOT DEBILITATING AND THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENTS BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVELY WAS 30 AND BSCVA POST OPERATIVE WAS REPORTED AS 20. ON (B)(6) 2024 DURING A YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT) EVALUATION THE PCO IN THE LEFT EYE WAS RESOLVED BY THE YAG LASER CAPSULOTOMY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THIS REPORT CAPTURES THE LEFT EYE. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0003094.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877056 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531697

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention