BEUDAMED
    FDA Enforcement Class II Terminated

    ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

    Recall: Z-1865-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1865-2021
    Event ID
    87947
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Johnson & Johnson Vision Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    May 6, 2021
    Classification Date
    June 16, 2021
    Termination Date
    November 2, 2021
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517, United States

    Description

    ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

    Reason

    Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

    Code Info

    UPC 733905989612 LOT # BOOWWWL

    Distribution

    Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.

    Quantity

    6,780 lenses