BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 18823458 · Received March 3, 2024

    Report

    Report Number
    3012304651-2024-00052
    Event Type
    Malfunction
    Date Received
    March 3, 2024
    Report Date
    March 3, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4). HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. ON 15TH FEBRUARY 2024, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING A SURGERY WITH RAYONE TORIC RAO210T. THE EVENT DESCRIPTION PROVIDED STATES THAT HE THEATRE, PRIOR TO THE SURGERY SESSION 2X RAYONE TORIC RAO610T IOLS (ORIGINAL, AND A BACK-UP DEVICE FROM THE SAME BATCH) WERE IDENTIFIED AS OUT OF LABELLED EXPIRY DATE (SEE ALSO C240371 - FDA MDR 3012304651-2024-00051). THE DEVICES WERE NOT USED; HOWEVER, ADDITIONAL INFORMATION RECEIVED STATES THAT PRIOR THIS OBSERVATION, THE PATIENT WAS ALREADY FULLY PREPARED FOR SURGERY WITH ANAESTHETIC. RAYONE PRODUCTS ARE LABELLED WITH "DO NOT USE AFTER EXPIRY".

    Description of Event or Problem · 0

    ON 15TH FEBRUARY 2024, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING A SURGERY WITH RAYONE TORIC RAO210T. THE EVENT DESCRIPTION PROVIDED STATES THAT HE THEATRE, PRIOR TO THE SURGERY SESSION 2X RAYONE TORIC RAO610T IOLS (ORIGINAL, AND A BACK-UP DEVICE FROM THE SAME BATCH) WERE IDENTIFIED AS OUT OF LABELLED EXPIRY DATE (SEE ALSO C240371 - FDA MDR 3012304651-2024-00051). DEVICE NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165069 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 029130887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown