BEUDAMED
    FDA Enforcement Class II Ongoing

    Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

    Recall: Z-1198-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1198-2023
    Event ID
    91607
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperVision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    January 26, 2023
    Classification Date
    March 1, 2023
    Address
    180 Thruway Park Dr, N/A, West Henrietta, NY, 14586-9798, United States

    Description

    Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

    Reason

    Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

    Code Info

    UDI: N/A Lot Numbers: R24395839, R24406094, R24409954

    Distribution

    US Nationwide distribution in the states of CA, OH, NC, PA.

    Quantity

    4 units