Events

Recall of Device Recall FreshLook Colors

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

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
    28542
  • Event Risk Class
    Class 3
  • Event Number
    Z-0741-04
  • Event Initiated Date
    2004-03-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32097
  • 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, Extended Wear - Product Code LPM
  • Reason
    The lens inside the package does not match the prescription information labeled on the primary package.
  • Action
    Consignees were notified by letter on 3/11/2004.

Device

Device Recall FreshLook Colors
  • Model / Serial
    Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date 2006-11, Lot #065530, Exp. Date 2006-11, Lot #079803, Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot #0-65427, Exp. Date: 2006-11.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
  • Product Description
    FreshLook¿ Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11440 Johns Creek Pkwy, Duluth GA 30097-1518
  • Source
    USFDA