BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23331233 · Received October 17, 2025

    Report

    Report Number
    3012236936-2025-000273
    Event Type
    Injury
    Date Received
    October 17, 2025
    Report Date
    October 18, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, AND A5 (ETHNICITY): UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3 - DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED. SECTION D4 - CATALOG #: A COMPLETE NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IT WAS REPORTED THAT THE LENS WAS A "DIB00 TECNIS EYHANCE INTRAOCULAR LENS". SECTION D4 - SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL INITIALLY REPORTED POTENTIAL POST-OPERATIVE IRITIS IN TWO PATIENTS ASSOCIATED WITH THE TECNIS EYHANCE INTRAOCULAR LENS (IOL). THESE PRELIMINARY REPORTS HAVE BEEN DOCUMENTED UNDER MEDWATCH MANUFACTURING REPORT NUMBERS 3012236936-2025-0002440 AND 3012236936-2025-0002441 (PERTAINING TO TWO EYES OF A SINGLE PATIENT), AS WELL AS 3012236936-2025-0002189. FOLLOWING FURTHER FOLLOW-UP WITH THE PHYSICIAN, THREE ADDITIONAL CASES OF IRITIS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS SUBMISSION REPRESENTS THREE (3) OF THREE (3) REPORTS. SEPARATE REPORTS WILL BE SUBMITTED FOR EACH OF THE REMAINING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409038 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other