BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23612963 · Received November 20, 2025

    Report

    Report Number
    3012236936-2025-000304
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    May 19, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810785
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: DEC 11, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: TWO LENSES WERE RECEIVED INSIDE SEPARATE PLASTIC BAGS WITH A PIECE OF FOAM. THESE LENSES WERE RECEIVED FOR THE SAME RETURNED GOODS AUTHORIZATION (RGA). SINCE IT COULD NOT BE CONFIRMED WHICH EVENT BELONGS TO WHICH LENS, BOTH LENSES WERE EVALUATED IN EACH INVESTIGATION. EVALUATION RESULTS ARE PROVIDED IN THIS MANUFACTURER REPORT NUMBER AND IN MANUFACTURER REPORT NUMBER 3012236936-2025-0003212. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE FIRST LENS (LENS #1) WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRN00V MODEL LENS. THE SECOND LENS (LENS # 2) WAS VISUALLY INSPECTED AND FOUND THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRN00V MODEL LENS. NO FURTHER ISSUES WERE OBSERVED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE EXAM THE PATIENT REPORTED THAT THEIR COMPUTER VISION IS TERRIBLE AND THEIR READING IS NOT GOOD. THE IOL WAS EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS MODEL EN+21.0. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVELY WAS REPORTED AS 20/20 -1. POST-OPERATIVE BCVA WAS 20/20 -1. THE CUSTOMER INDICATED THAT THEY FOLLOWED THE DIRECTIONS FOR USE. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES VITRECTOMY OR DELAY IN THE PROCEDURE. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023861 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810785

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention