Events

Recall of Acuvue Advance for Astigmatism Diagnostic Product.

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

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
    52828
  • Event Risk Class
    Class 3
  • Event Number
    Z-2012-2009
  • Event Initiated Date
    2009-04-20
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84455
  • 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
    Vistakon is recalling acuvue advance for astigmatism diagnostic product for mislabeling.
  • Action
    Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.

Device

Acuvue Advance for Astigmatism Diagnostic Product.
  • Model / Serial
    B007NV51 and B0077KM1.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Acuvue Advance for Astigmatism Diagnostic Product. || Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. || Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. || Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.
  • Manufacturer
    Vistakon

Manufacturer

Vistakon
  • Manufacturer Address
    Vistakon, 7500 Centurion Pkwy Ste 100, Jacksonville FL 32256-0517
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA