BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 22390979 · Received July 2, 2025

    Report

    Report Number
    3012236936-2025-000184
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 13, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811348
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 MISSING THE ¿P¿ BEFORE THE NUMERICAL VALUE. THE COMPLETE NUMBER IS P980040. 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. THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. THEREFORE, IT WAS NOT EXPLANTED. SECTION D10, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: OVD IS OPHTHALMIC VISCOSURGICAL DEVICE. BSS IS BALANCED SALT SOLUTION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JUL 17, 2025. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT SIMPLICITY WAS VISUALLY INSPECTED UNDER MAGNIFICATION REVEALING THAT THE PLUNGER ROD WAS FULLY ADVANCED. A STRESS MARK WAS OBSERVED ON THE CARTRIDGE AND CARTRIDGE TIP LEADING TO A DEFORMATION ON THE CARTRIDGE TIP. OVD WAS OBSERVED INSIDE THE CARTRIDGE. THE LENS MODULE, PLUNGER ROD, AND HANDPIECE WERE INSPECTED, AND NO ISSUES WERE IDENTIFIED. THE LENS WAS EVALUATED AND OBSERVED TO BE CUT IN HALF. DAMAGE ON THE SURFACE OF THE LENS WAS ALSO OBSERVED. NO FURTHER ISSUES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS JAMMED INTO THE INSERTER BY THE INJECTOR WHICH PUSHED OFF, WENT OFF TO THE SIDE. THE INJECTOR WOULD NOT RELEASE THE LENS TO FULLY GO INTO THE PATIENT¿S RIGHT EYE CONSEQUENTLY; THE LENS WAS PARTIALLY INSERTED. THE IOL HAD TO BE REMOVED AND THE DOCTOR USED FORCEPS TO GET THE LENS OUT OF THE INCISION. A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. BOTH THE BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WERE ALLOWED TO ACCLIMATIZE FULLY TO ROOM TEMPERATURE. ADDITIONALLY, AFTER THE INSERTER WAS PREPARED, THERE WERE NO DELAYS IN THE SURGERY BEFORE ADVANCING THE LENS. WHEN THE LENS WAS ADVANCED IT INITIALLY MOVED A LITTLE AND THEN GOT STUCK AND THE LENS WAS NOT POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN NORMAL. THE CUSTOMER REPORTED THAT THE INJECTOR IN THE CARTRIDGE TENDS TO GO OFF TO THE SIDE A LOT. USUALLY, OFF TO THE RIGHT. THE PATIENT OUTCOME WAS REPORTED AS ¿GOOD¿. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175803 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811348

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female OVD AND BSS.