BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 20163563 · Received September 6, 2024

    Report

    Report Number
    3012236936-2024-000245
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    September 4, 2024
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811935
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GU, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5, A6: UNKNOWN/ NOT APPLICABLE SINCE NO PATIENT CONTACT. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS NO INDICATION THAT LENS WAS IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS NO INDICATION THAT LENS WAS IMPLANTED, HENCE NOT EXPLANTED. SECTION H3- NO: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TORIC WAS DAMAGED IN THE PRELOADED INJECTOR AND IT WAS NOT IMPLANTED. THE SURGERY TECH (VERY EXPERIENCED TECH) TOLD THE SURGEON THAT THE PLUNGER WOULD NOT ADVANCE AND SHE DIDN'T WANT TO PUT ANY MORE FORCE ON IT. THE SURGEON INSPECTED IT UNDER THE SCOPE BUT COULD NOT SEE WHY IT WOULD NOT ADVANCE. AS THE CUSTOMER ONLY ORDER ONE LENS AND NO BACKUP, BEFORE LEAVING THE PATIENT APHAKIC, AND THE SURGEON HOPED THAT HE COULD SALVAGE THE IOL AND LOAD IT MANUALLY. THE SURGEON THEN CUT THROUGH THE INJECTOR PLASTIC BEHIND THE LENS. ONCE THE SURGEON HAD A SMALL WINDOW TO SEE THE LENS, HE COULD SEE THAT ONE OF THE HAPTICS HAD BROKEN OFF, THEREFORE HE KNEW THAT HE COULD NOT SALVAGE THE IOL. REGARDLESS, THE SURGEON LEFT THE PATIENT APHAKIC. IT WAS NOTED THAT THERE WAS NO PATIENT CONTACT WITH THE PRODUCT AND THAT A SECONDARY IOL PLACEMENT WILL OCCUR WHEN IOL ARRIVES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225590 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474811935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male