Events

Recall of AIR OPTIX

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
    55570
  • Event Risk Class
    Class 2
  • Event Number
    Z-1706-2010
  • Event Initiated Date
    2010-04-27
  • Event Date Posted
    2010-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91151
  • 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 lenses inside the package do not match the prescription information for power labeled on the primary package.
  • Action
    CIBA Vision, Corp. notified consignees of the affected product via letter beginning April 15, 2010. Users were asked to return the product to the firm. For further information, contact your CIBA Vision sales representative or call 1-877-542-5928.

Device

AIR OPTIX
  • Model / Serial
    Lot Number: 8717082, Exp. 10/2013, Label Power: -0.50, Cylinder: -1.75, Axis: 180; and Lot Number: 8717066, Exp. 10/2013, Label Power: -2.50, Cylinder -1.75, Axis 180.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI.
  • Product Description
    AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. || Toric lenses approved for daily wear and extended wear up to 6 nights.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11460 Johns Creek Pkwy, Duluth GA 30097
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA