BEUDAMED
    FDA Enforcement Class II Ongoing

    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

    Recall: Z-1338-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1338-2022
    Event ID
    90301
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Rayner Intraocular Lenses Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 13, 2022
    Initiation Date
    May 13, 2022
    Classification Date
    July 6, 2022
    Address
    10 Dominion Way, N/A, Worthing, N/A, N/A, United Kingdom

    Description

    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

    Reason

    The outer package is mislabeled and the package contains a different IOL strength.

    Code Info

    Outer carton +19.0 D - Batch #012183745, exp. 1/17/2024, Serial numbers 01-06, 10, 21, 24-45, 48-53, 58-60, 61-65, and 68-81, UDI (01)05029867006685. Outer carton +21.0 D - Batch #012183845, exp. 1/17/2024, all serial numbers, UDI (01)05029867006722.

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.

    Quantity

    162 IOLs