BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24370880 · Received February 17, 2026

    Report

    Report Number
    3012236936-2026-000040
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 25, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810877
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: MAR 6, 2026. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. THE LENS WAS VISUALLY INSPECTED REVEALING THAT ONE HAPTIC WAS DETACHED. NO FURTHER ISSUES WERE IDENTIFIED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRN00V MODEL LENS. 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.

    Additional Manufacturer Narrative · 0

    SECTION A6, RACE: UNKNOWN/NOT PROVIDED. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. 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. IT WAS REPORTED THAT THERE WAS AN IOL MECHANICAL COMPLICATION DUE TO THE PATIENT WAS UNHAPPY WITH THEIR GLARE AND HALOS FROM THE ODYSSEY LENS. THE SYMPTOMS WERE DEBILITATING AS THEY COULD NOT DRIVE AT NIGHT. BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVELY WAS REPORTED AS 20/30, POST OPERATIVELY WAS 20/35. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿FULLY RECOVERED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434457 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810877

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention