BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23040184 · Received September 12, 2025

    Report

    Report Number
    3012236936-2025-000244
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    April 1, 2025
    Report Date
    October 23, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731660
    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

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENTS WITH POTENTIAL POST-OPERATIVE IRITIS WERE LIMITED TO DR. (B)(6) PATIENTS. THE INFORMATION RECEIVED CLARIFIED THAT THE HEALTHCARE PROFESSIONAL INITIALLY REPORTED POTENTIAL POST-OPERATIVE IRITIS IN TWO PATIENTS ASSOCIATED WITH THE TECNIS EYHANCE INTRAOCULAR LENS (IOL) WHICH THE PRELIMINARY REPORTS FOR THE TWO PATIENTS HAVE BEEN DOCUMENTED UNDER MEDWATCH MANUFACTURING REPORT NUMBERS 3012236936-2025-0002440 AND 3012236936-2025-0002441 (PERTAINING TO TWO EYES OF A SINGLE PATIENT, WITH ONE EYE CAPTURED IN THE INITIAL MDR REPORT OF THIS CURRENT REPORT), AS WELL AS 3012236936-2025-0002189. FOLLOWING FURTHER FOLLOW-UP WITH THE PHYSICIAN, THREE ADDITIONAL CASES OF IRITIS WERE INDICATED WHICH HAVE BEEN REPORTED UNDER MEDWATCH MANUFACTURING REPORT NUMBERS (3012236936-2025-0002717, 3012236936-2025-0002729 & 3012236936-2025-0002730). THE FOLLOWING ADDITIONAL CODE WAS ADDED: SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2122 - UVEITIS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: FEMALE. SECTION A-5 PATIENT ETHNICITY: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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 REPORT WILL BE FILED. SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 4581 DEVICE DECENTERED/DISLOCATED SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 4471 - PIGMENT DISPERSION TO THE IOL. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT HAD PERSISTENT ANTERIOR CHAMBER REACTION (AC RXN) IN BOTH EYES DESPITE AN UNCOMPLICATED CATARACT SURGERY. THE DOCTOR BELIEVES THE ANTERIOR TILT OF THE HAPTICS AND SLIGHTLY LARGER HAPTIC WIDTH ARE CAUSING MORE CILIARY BODY-TO-HAPTIC TOUCH INDUCING THIS CHANGE. IN THIS PATIENT HAPTIC-CILIARY BODY BAND (CBB) TOUCH WAS CONFIRMED WITH ULTRASOUND BIOMICROSCOPY (UBM) AND THE DOCTOR OBSERVED NEW PIGMENT DISPERSION TO THE IOL. PATIENT SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE HER DAILY ACTIVITIES CAUSING DISCOMFORT AND PHOTOPHOBIA. PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/40 AND POST-OPERATIVE UNCORRECTED AND BEST-CORRECTED VISUAL ACUITY WAS 20/25 +1. THERE WAS NO PATIENT INJURY DURING THE INITIAL PROCEDURES. AN IOL EXCHANGE IS SCHEDULED FOR ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527361 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other