Recall of Device Recall Encore and OneVue

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coopervision Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26532
  • Event Risk Class
    Class 3
  • Event Number
    Z-0978-03
  • Event Initiated Date
    2003-06-25
  • Event Date Posted
    2003-07-03
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2005-04-11
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Reason
    The actual sphere power of the lens is lower than the labeled value.
  • Action
    Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.

Device

  • Model / Serial
    There are 768 lot numbers as follows: 3669001157,  3669001465,  3669001756,  3669001960,  3669002711,  3669002714,  3669002816,  3669003208,  3669003214,  3669500011,  3669500414,  3669500514,  3779000756,  3779001722,  3779002117,  3779002513,  3779002911,  3779003020,  3779003624,  3779003906,  3779005316,  3779500013,  3779500120,  3890000722,  3890001706,  3891001712,  3892000954,  3892001402,  3892001414,  3892001712,  3893001417,  3893001611,  3893001711,  3893002612,  3893002613,  3893002712,  3893003020,  3893003107,  3893003302,  3893003614,  3893004706,  3893004806,  3893500111,  3893500702,  3893500802,  3893500902,  3894001058,  3894001560,  3894001654,  3894002213,  3894002607,  3894002610,  3894002811,  3894003005,  3894004306,  3894004502,  3894004904,  3894005004,  3894500205,  3894500310,  3894500311,  3894500313, 3894500402,  3894500411,  3894500511,  3894500704,  3894500706,  3895001456, 3895002758,  3895002855,  3895003024,  3895003220,  3895003315,  3895003320, 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
  • Product Description
    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) || and (2) ONEVUE 55 toric (methafilcon A) flexible wear. || Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Coopervision Inc, 711 North Road, Scottsville NY 14643
  • Source
    USFDA