BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23901064 · Received December 26, 2025

    Report

    Report Number
    3012236936-2025-000331
    Event Type
    Injury
    Date Received
    December 26, 2025
    Report Date
    December 27, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655416
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: DATE UNKNOWN SECTION D6B - EXPLANT DATE: NOT APPLICABLE - LENS REMAINS IMPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - 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 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY AND IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED PERSISTENT MONOCULAR DOUBLE VISION IN THE RIGHT EYE. DESPITE VARIOUS CORRECTIVE MEASURES AND COMPREHENSIVE VISUAL AND MEDICAL TESTING, THE DOUBLE VISION REMAINED UNRESOLVED. THE PATIENT UNDERWENT AN YTTRIUM-ALUMINIUM-GARNET (YAG) CAPSULOTOMY ON (B)(6) 2025 BUT CONTINUED TO REPORT DOUBLE VISION AND DISSATISFACTION WITH VISUAL OUTCOMES, INCLUDING DIFFICULTY RECOGNIZING FACES AND SIGNS AT A DISTANCE, AND ONGOING HEADACHES. THE PATIENT IS TEMPORARILY IMPAIRED AND DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. THE LENS REMAINS IMPLANTED, AND THERE IS NO PLAN TO EXPLANT IT. PRIOR TO SURGERY (ON (B)(6) 2025), THE PATIENT WOULD SOMETIMES SEE LIGHTNING BOLTS ALL DAY. IT WAS DETERMINED THAT THIS IS NOT DUE TO AN OCULAR MIGRAINE. THE PATIENT EXPERIENCED SIGNIFICANT VISUAL DIFFICULTIES WITH THE COMPUTER; AND HAD A STRONG FEAR OF SURGERY. THE PATIENT DESIRED MINIMAL RISK. FEMTOSECOND CATARACT SURGERY WAS REQUESTED DUE TO ITS MINIMALLY INVASIVE NATURE. A TORIC IOL WAS DELIBERATELY NOT RECOMMENDED FOR THE LEFT EYE DUE TO THE RISK OF REQUIRING A SECOND SURGERY IF THE TORIC IOL ROTATES. PRE-EXISTING CONDITION: CONGENITAL HEART DEFECT; OCCLUDED ANEURYSM IN THE HEART VISUAL ACUITY (B)(6) 2025 CC (WITH CORRECTION) OD (RIGHT EYE) =0.6-0.8PP OS (LEFT EYE) = 0.6P GBN LM. FOLLOWING IOL IMPLANTATION ON (B)(6) 2025 OD, THE PATIENT CAN NOW SEE COLORS MORE CLEARLY AND NO LONGER NEEDS GLASSES WHEN WORKING AT A COMPUTER SCREEN. ON (B)(6) 2025, THE PATIENT REPORTED NOT BEING ABLE TO SEE WELL WITH THE RIGHT EYE. ON (B)(6) 2025, THE PATIENT REPORTED ISSUES WITH THE RIGHT EYE, FOREIGN BODY SENSATION, CLOUDY, CONSTANT HEADACHE, PAIN IN THE UPPER EYELID, NOTING A TEMPORAL LINE. IOL WAS CLEAR AND IN CORRECT POSITION. HYLOGEL WAS PRESCRIBED TO BE USED EVERY 2 HOURS, AND ARTELAC NIGHT TO BE USED IF NECESSARY. ON (B)(6) 2025, THE PATIENT REPORTED NOT BEING SATISFIED WITH THE IOL IN THE RIGHT EYE, REPORTING BLURRY VISION, NO CLEAR IMAGES IN DISTANCE, SOMETIMES DOUBLE VISION, PATIENTS AND SIGNS VERY BLURRY. PATIENT HAD A HEADACHE AND DULL FEELING IN HER HEAD FOR A MONTH AFTER SURGERY AND INQUIRED IF THIS CAN BE FROM THE ANESTHETICS USED DURING SURGERY. CAPSULAR FIBROSIS RIGHT EYE. THEALOZ DUO, ATR 10 ML WAS PRESCRIBED FOR THE RIGHT EYE TO BE USED AT LEAST 4 TIMES A DAY THE SURGERY FOR THE LEFT EYE WAS CANCELED DUE TO PATIENT BEING CONCERNED OF ALSO EXPERIENCING ISSUES IN THE LEFT EYE IN CASE OF SURGERY. (B)(6) 2025 YAG CAPSULOTOMY WAS PERFORMED IN THE RIGHT EYE. PATIENT COMPLAINS OF SEEING WORSE THAN BEFORE SURGERY. CONSTANT HEADACHES ON THE RIGHT SIDE OF HER HEAD. VOLTAREN OPHTA SINE EDP, ATR 20X0.3ML N2 3 TIMES A DAY FOR 1 WEEK PRESCRIBED OD= 10 MMHG. OD SC (WITHOUT CORRECTION): 0,4PP NW. ON (B)(6) 2025, THE PATIENT REPORTED DOUBLE VISION, NO IMPROVEMENT IN SUBJECTIVE VISION, PERSISTENT MONOCULAR DOUBLE VISION, PATIENT VERY DISSATISFIED, CANNOT DRIVE DUE TO THE ISSUES EXPERIENCED. ON (B)(6) 2025 REFRACTION WITH ORBSCAN: PATIENT CAN SEE BIG LETTERS WITH SLIGHT SHADOW, HOWEVER CANNOT READ WORDS. NO DOUBLE VISION IN FRONT OF COMPUTER, HOWEVER ALREADY GETS TIRING AFTER 1 HOUR. MONOCULAR DOUBLE VISION MORE SO IN DISTANCE AND DIFFICULTY RECOGNIZING FACES. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138463 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention