BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 25257349 · Received May 22, 2026

    Report

    Report Number
    3012236936-2026-000144
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    July 18, 2024
    Report Date
    May 22, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502062
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS 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 THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 YAG (YTTRIUM ALUMINUM GARNET). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES, WITH SURGERIES PERFORMED WITHIN A TWO-WEEK INTERVAL. YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY WAS CONDUCTED IN BOTH EYES APPROXIMATELY 30 DAYS POSTOPERATIVELY FOR TREATMENT OF SCAR TISSUE, PER PATIENT REPORT. THE PATIENT HAS A MEDICAL HISTORY OF RETINOPATHY, WITH APPROXIMATELY 4¿5 PRIOR LASER PROCEDURES PERFORMED IN BOTH EYES BEFORE CATARACT SURGERY. POSTOPERATIVELY, THE PATIENT INDICATED THAT UNCORRECTED VISION WAS SATISFACTORY; HOWEVER, WHEN USING PRESCRIPTION EYEGLASSES, A PERSISTENT YELLOW TINT WAS PERCEIVED, RATED AS 1/10 WITH THE INITIAL PAIR AND 4.5/10 WITH A SECOND PAIR OF TRANSITIONAL LENSES. THE PATIENT DECLINED THE SECOND PAIR DUE TO THE SAME ISSUE. THE EYEGLASS TECHNICIAN ALSO REPORTEDLY OBSERVED A SLIGHT YELLOW TINT WHEN VIEWING THROUGH THE EYEGLASSES. THE TREATING PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE YELLOW TINT ASSOCIATED WITH GLASSES USE. DESPITE OVERALL GOOD VISUAL ACUITY, THE PATIENT REPORTED INCONVENIENCE REQUIRING THE USE OF SUNGLASSES OVER PRESCRIPTION GLASSES WHILE DRIVING. THE PATIENT ELECTED TO USE CLIP-ON/FLIP-UP SUNGLASSES AS A MANAGEMENT APPROACH. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576735 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502062

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention