BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 24527336 · Received March 5, 2026

    Report

    Report Number
    3012236936-2026-000061
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Report Date
    May 6, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATE IS UNKNOWN/NOT PROVIDED. BEST ESTIMATE DATE IS PRIOR TO FEB 10, 2026. SECTION D4: MODEL NUMBER: A COMPLETE MODEL # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. THE BAST ESTIMATE IS A "DRT" MODEL LENS. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. THE BAST ESTIMATE IS A "DRT" LENS. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. A COMPLAINT HISTORICAL REVIEW OF THE MANUFACTURING PRODUCTION ORDER NUMBER CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE SERIAL NUMBER IS UNKNOWN, AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. ATTEMPTS HAVE BEEN MADE WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT OCCASIONAL AND SEVERE RESISTANCE HAS BEEN OBSERVED WITH THE ODYSSEY PRELOADED INTRAOCULAR LENS (IOL) INJECTORS, DESPITE THE USE OF BALANCED SALT SOLUTION (BSS) OR OPHTHALMIC VISCOELASTIC DEVICE (OVD). THE PLUNGER HAS SCRATCHED SOME INTRAOCULAR LENSES (IOLS), AND IN A FEW INSTANCES, THE PLUNGER TORE THROUGH THE CARTRIDGE WHILE ATTEMPTING TO ADVANCE THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495674 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown