Events

Recall of CooperVision Contact Lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 1-800 Contacts 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
    30238
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-05
  • Event Initiated Date
    2004-10-13
  • Event Date Posted
    2004-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35540
  • 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
    Lens, Contact, (Disposable) - Product Code MVN
  • Reason
    Identified lots of proclear compatible contact lenses are counterfeit and may not be sterile.
  • Action
    Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.

Device

CooperVision Contact Lenses
  • Model / Serial
    (Identified as Lot number , power):  200218733K, -0.75; 200221583L, -1.00; 200221758L, -1.25; 200217599K, -1.50; 200219058K; -1.75; 200203444G, -2.00; 200217595K, -2.25; 200221190L, -2.50; 200219740K, -2.75; 200217588K, -3.00; 200323296A, -3.25; 200222445L, -3.50; 200325268A, -3.75; 200292234E, -4.00; 2002922484E, -4.00; 200213996J, -4.25; 200218908K, -4.50; 200214236J, -4.75; 200215709J, -5.00; 200212242J, -5.25; 200325303A, -5.50; 200213136J, -5.75; 200213135J, -6.00; 200208401H, -6.50; 200219479K, -7.00; and 200218545K, -7.50.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia.
  • Product Description
    Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.
  • Manufacturer
    1-800 Contacts Inc.

Manufacturer

1-800 Contacts Inc.
  • Manufacturer Address
    1-800 Contacts Inc., 66 Wadsworth Park Dr, Draper UT 84020-7942
  • Source
    USFDA