BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 23439338 · Received October 31, 2025

    Report

    Report Number
    3012236936-2025-000270
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 29, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474747074
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. DATE RETURNED TO MANUFACTURER: NOV. 12, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD PARTIALLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED THROUGHOUT THE CARTRIDGE. NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE, LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, AND PLUNGER ROD ADVANCEMENT. THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED REVEALING THAT THE LENS WAS TORN. A BLUE FIBER-LIKE MATERIAL WAS RECEIVED INSIDE THE SPECIMEN CUP. THE FIBER WAS FORWARDED TO AN INDEPENDENT LABORATORY FOR ANALYSIS. PER INDEPENDENT LABORATORY, THE MATERIAL WAS A MIXTURE OF SODIUM HYALURONATE AND CELLULOSE (E.G., COTTON, LINT). THE FTIR SPECTRUM WAS COMPARED TO THE MANUFACTURING FTIR LIBRARY AND DID NOT PRODUCE A STRONG MATCH; THE TOP MATCH WAS CLEAN ROOM PAPER BUT WITH A LOW CORRELATION. A COMPLAINT OF LOOSE FOREIGN MATERIAL WAS NOTED DURING PRODUCT EVALUATION, BUT THE INVESTIGATION DID NOT CONFIRM A CONNECTION TO MANUFACTURING OR DESIGN. THE OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. 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 THIS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED, TORIC II MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR WAS FOUND TO HAVE PLASTIC DEBRIS AT THE NOZZLE TIP DURING THE INSERTION OF A LENS INTO A PATIENT'S RIGHT EYE (OD). IT WAS CONFIRMED THAT THE IOL WAS NOT STUCK. THE LENS WAS NOT FULLY ADVANCED, AND THE INJECTOR WITH THE LENS WAS REMOVED FROM THE EYE UPON DETECTION OF THE DEBRIS. THE PATIENT DID NOT SUSTAIN ANY INJURY, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE NECESSARY. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE DEBRIS, DESCRIBED AS RESEMBLING A SMALL PIECE OF BLUE POLYESTER FABRIC, ALONG WITH THE LENS. IT WAS NOTED THAT THE ISSUE WAS NOT DUE TO USER ERROR. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563249 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474747074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male