BEUDAMED
    FDA Enforcement Class II Ongoing

    MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

    Recall: Z-1014-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1014-2023
    Event ID
    91389
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperVision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 27, 2022
    Classification Date
    January 24, 2023
    Address
    180 Thruway Park Dr, N/A, West Henrietta, NY, 14586-9798, United States

    Description

    MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

    Reason

    Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

    Code Info

    Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI

    Distribution

    Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.

    Quantity

    6,570 lenses