BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 20044596 · Received August 22, 2024

    Report

    Report Number
    3012236936-2024-000235
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811997
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AUTOREFRACTOR REPORTING PATIENT TO HAVE 2.25D (DIOPTER) OF RESIDUAL CYLINDER- WAITING ON MANIFEST REFRACTION, 12 DEGREES OFF FROM TARGET TORIC AXIS. THE ISSUE WAS NOTED DURING THE POST OPERATIVE EXAMINATION. IT IS UNKNOWN IF THERE WERE ANY MEDICAL OR SURGICAL INTERVENTIONS. NO DELAY IN PROCEDURE REPORTED. THE LENS REMAINS IMPLANTED. THE PATIENT OUTCOME STATUS IS UNKNOWN AND IT IS UNKNOWN IF THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH PATIENT'S DAILY ACTIVITY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256755 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474811997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown