Events

Recall of Device Recall Frequency 55

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
    26795
  • Event Risk Class
    Class 3
  • Event Number
    Z-1091-03
  • Event Initiated Date
    2003-07-22
  • Event Date Posted
    2003-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28466
  • 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
    Mislabeled with incorrect sphere power.
  • Action
    Customers notified via telephone on 7/22/03.

Device

Device Recall Frequency 55
  • Model / Serial
    1468-212, Exp. 10/2008
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. 33 eye care practitioners in the following states: AR, AL, CA, DE, FL, GA, IA, KS, MI, MA, NJ, NY, NC, OH, OK, PA, TX, UT, VA, and WI. Lenses were also shipped to Coopervision affiliates in the United Kingdom and Canada.
  • Product Description
    Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
  • Manufacturer
    Coopervision Inc

Manufacturer

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