BEUDAMED
    FDA Enforcement Class II Ongoing

    RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

    Recall: Z-1753-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1753-2020
    Event ID
    85270
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Rayner Intraocular Lenses Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    March 17, 2020
    Classification Date
    April 21, 2020
    Address
    The Ridley Innovation Centre, 10 Dominion Way, Worthing, N/A, N/A, United Kingdom

    Description

    RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

    Reason

    RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.

    Code Info

    LOT K030.

    Distribution

    US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.

    Quantity

    2425 Units.