BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22821726 · Received August 15, 2025

    Report

    Report Number
    3012236936-2025-000218
    Event Type
    Injury
    Date Received
    August 15, 2025
    Report Date
    October 23, 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

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION A6: RACE: BLACK OR AFRICAN AMERICAN. 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), AS WELL AS 3012236936-2025-0002189 (CAPTURED IN THE INITIAL MDR REPORT OF THIS CURRENT REPORT). 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). ADDITIONAL INFORMATION/CORRECTED DATA: IN THE INITIAL MDR REPORT, DR. (B)(6) WAS INADVERTENTLY ENTERED IN THE SECTION E1 OF THE INITIAL MDR REPORT WHICH IS INCORRECT. BASED ON THE ADDITION INFORMATION RECEIVED, THE CORRECT DOCTOR IS DR. (B)(6). THE FOLLOWING FIELDS WERE CORRECTED/UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION E1: FIRST/GIVEN NAME: (B)(6). SECTION E1: LAST NAME: (B)(6). SECTION E1: EMAIL ADDRESS: (B)(6). SECTION E1: ESTABLISHMENT NAME: (B)(6). SECTION E1: ADDRESS - LINE 1: (B)(6). SECTION E1: (B)(6). SECTION E1: POST OFFICE OR ZIP CODE: (B)(6). SECTION E1: TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: SECTION B3: DATE OF EVENT: EXACT DATE IS UNKNOWN/NOT PROVIDED. BEST ESTIMATE DATE IS PRIOR TO JUL 23, 2025. SECTION D6A. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. SECTION D4: CATALOG NUMBER: THE COMPLETE CATALOG NUMBER IS UNKNOWN, AS SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. BEST ESTIMATE IS THAT THE LENS IS AN ENHANCE LENS, MODEL DIB00. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. SECTION E1: INITIAL REPORTER ADDRESS (STREET ADDRESS, CITY, STATE & ZIP CODE): UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1: INITIAL REPORTER PHONE NUMBER: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION 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 SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, THE INFORMATION WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT SEVERAL SURGEONS HAD EXPRESSED CONCERNS REGARDING POTENTIAL HAPTIC-CILIARY BODY CONTACT WITH THE ENHANCE INTRAOCULAR LENS (IOL). THIS OBSERVATION WAS BASED ON ULTRASOUND BIOMICROSCOPY (UBM) FINDINGS IN A FEW PATIENTS WHO EXPERIENCED PERSISTENT POSTOPERATIVE IRITIS FOLLOWING ROUTINE CATARACT SURGERY. SUBSEQUENTLY, THE DOCTOR CLARIFIED THAT THE UBM FINDINGS ARE INCIDENTAL AND DO NOT INDICATE AN IOL-SPECIFIC ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295993 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other