BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23156953 · Received September 26, 2025

    Report

    Report Number
    3012236936-2025-000240
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 4, 2025
    Report Date
    January 6, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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: 06-OCT-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT. THE PLUNGER ROD WAS FOUND FULLY ADVANCED WITH VISCOELASTIC RESIDUE OBSERVED THROUGHOUT THE CARTRIDGE. STRESS MARKS WERE OBSERVED ON THE CARTRIDGE TIP AND A SLIGHT BULGE WAS ALSO OBSERVED ON THE CARTRIDGE TIP. NO ISSUES WERE IDENTIFIED WITH THE LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, OR PLUNGER ROD ADVANCEMENT. NO LENS WAS RECEIVED FOR EVALUATION. THEREFORE, NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "COSMETIC ISSUES" AND "STUCK IN CARTRIDGE" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION AS NO LENS WAS RECEIVED. THE OTHER ISSUES OBSERVED COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. 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 D6B - EXPLANT DATE: NOT APPLICABLE - LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - 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 DURING THE PREPARATION OF THE PRELOADED INTRAOCULAR LENS (IOL) FOR IMPLANTATION, THE LENS DID NOT ADVANCE IN THE CARTRIDGE. THE SURGEON ADDED A SMALL AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND ATTEMPTED THE PREPARATION AGAIN, AFTER WHICH THE LENS MOVED NORMALLY. THE IMPLANTATION PROCEEDED WITHOUT FURTHER ISSUES. HOWEVER, AFTER IMPLANTATION, A SMALL SCRATCH WAS NOTICED ON THE IOL. THE PATIENT IS SCHEDULED FOR A POST-OPERATIVE CHECK UP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113016 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown