BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23034011 · Received September 11, 2025

    Report

    Report Number
    3012236936-2025-000228
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 18, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474825215
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE PREVIOUSLY SUBMITTED FOLLOW UP REPORT MDR (FOLLOW UP # 1) WAS INADVERTENTLY SUBMITTED WITH AN INCORRECT DATE RECEIVED BY MANUFACTURER (12/11/2025) POPULATED IN SECTION G3. THE CORRECT DATE FOR SECTION G3 DATE RECEIVED BY MANUFACTURER FOR FOLLOW UP # 1 IS 12/12/2025. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT SECTION G4 (PMA/510(K) NUMBER) IN THE INITIAL MDR WAS INADVERTENTLY SUBMITTED WITH AN INCORRECT PMA NUMBER. THE CORRECT NUMBER IS P980040. THE FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION G4 - PMA/510(K) NUMBER: P980040 ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, PHOTOGRAPHS PROVIDED BY THE CUSTOMER WERE EVALUATED. THE PICTURES SHOWED AN EYE BEING IMPLANTED WITH AN INTRAOCULAR LENS (IOL) CLAIMED TO BE AN ODYSSEY IOL PRELOADED IN THE SIMPLICITY DELIVERY SYSTEM MODEL DRN00V. IT COULD BE OBSERVED THAT A BLACKISH PARTICLE THAT MEASURES APPROXIMATELY 2 X 1 MM WAS LOCATED PARACENTRAL TO THE PUPIL AND IN THE PUPILLARY PERIPHERY. PER COMPLAINT DESCRIPTION, THE PARTICLE WAS REMOVED AND IS NOT OBSERVED IN THE SUBSEQUENT PICTURES. THE NATURE OF THE PARTICLE, ITS SOURCE AND ITS POTENTIAL CLINICAL IMPACT COULD NOT BE DETERMINED FROM A PICTURE ASSESSMENT. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PHOTOGRAPH EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, 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 E1 - TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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 A PRELOADED INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S EYE HAD A PIECE OF PLASTIC STUCK IN THE FRONT OF THE IOL. THE LENS WAS INTACT. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE LENS REMAINS IMPLANTED. THE PIECE OF PLASTIC WAS TAKEN OUT OF THE PATIENT'S EYE AND DESTROYED. NO FURTHER DETAIL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676313 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474825215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown