BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24776651 · Received April 3, 2026

    Report

    Report Number
    3012236936-2026-000074
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 3, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474825307
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: NO. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: NOT RETURNED SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: NO DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED PHOTO WAS EVALUATED. THE PICTURE SHOWS A LENS CLAIM TO BE A TECNIS ODYSSEY WITH SIMPLICITY DELIVERY SYSTEM. IT CAN BE OBSERVED FROM THE PHOTO THAT THE LENS IS CUT. NO OTHER ISSUES WERE OBSERVED. THE COMPLAINT ISSUES WERE NOT IDENTIFIED DURING PHOTO EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PHOTO EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATION. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A MEDICAL HISTORY SIGNIFICANT FOR HYPERLIPIDEMIA, A HYPOGESTIVE GLANDULAR DISORDER, AND PRIOR LASIK SURGERY PERFORMED IN 2010. ON (B)(6) 2020, THE PATIENT UNDERWENT IMPLANTATION OF A DRN 22.5 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), WITH A BARRETT TRUE-K TARGET REFRACTION OF -0.2 DIOPTERS. AT A POSTOPERATIVE FOLLOW-UP ON (B)(6) 2020, THE PATIENT HAD A CIRCLE MEASUREMENT OF 0.6 AND A MANIFEST REFRACTION SPHERICAL EQUIVALENT OF -1.0 DIOPTERS, ACHIEVING A CORRECTED VISUAL ACUITY OF 1.0. THE PATIENT REPORTED A MYOPIC SHIFT AND DISSATISFACTION WITH VISUAL ACUITY, WHICH HAD BEEN EXPECTED TO BE APPROXIMATELY 0.9¿1.0 WITH A REFRACTION OF PLANO TO -0.25 DIOPTERS. ON (B)(6) 2020, AN IOL EXCHANGE PROCEDURE WAS PERFORMED, DURING WHICH THE DRN 22.5 LENS WAS EXPLANTED AND REPLACED WITH A DRN 21.0 LENS. POSTOPERATIVELY, THE PATIENT¿S VISION WAS MONITORED, AND BLURRED VISION WAS NOTED DURING EXAMINATION. ADDITIONAL INFORMATION INDICATED THE PRESENCE OF DRY EYE AND A POSSIBLE ERROR IN THE PREOPERATIVE EXAMINATION. AT A FOLLOW-UP VISIT AFTER THE IOL EXCHANGE, THE PATIENT¿S VISUAL ACUITY WAS REPORTED AS 0.7 WITH A MANIFEST REFRACTION OF +0.5 DIOPTERS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840474 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474825307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention