BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1014-2023 · Initiated December 27, 2022

    Recall

    Recall Number
    Z-1014-2023
    Event Number
    91389
    Firm
    CooperVision, Inc.
    FEI Number
    3005724763
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 27, 2022
    Posted
    January 24, 2023
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798

    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.

    Action

    On December 27, 2022, the firm notified affected wholesale/distributor and Eye Care Practitioner consignees via Urgent Medical Device Correction letters. Customers were instructed to stop any further distribution of product from affected lot numbers and dispose of any affected product still in inventory. Customers may also return product. Customers who are affected by this recall are eligible for credit or replacement. Distributors and Eye Care Practitioners should also contact downstream Eye Care Practitioner customers as well as patients who have received product from the affected lots. Patients with questions may contact CooperVision's Customer Service team at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint.

    Distribution

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

    Quantity

    6,570 lenses