Events

Recall of Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)

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
    56460
  • Event Risk Class
    Class 3
  • Event Number
    Z-2445-2010
  • Event Initiated Date
    2010-07-16
  • Event Date Posted
    2010-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93722
  • 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
    Acuvue oasys brand contact lenses for astigmatism may be mislabeled on the outer (secondary) packaging carton. the outer (secondary) cartons labeled as lot b006x641 -8.50d -1.25cyl. 100 axis may actually contain primary packages from lot b006wbs1 -9.00d -1.25cyl. 80 axis. the inner (primary) package labeling is correct. product was only distributed to eye care professionals for use in proper f.
  • Action
    Vistakon issued an Important Product Notification dated July 28, 2010 to customers identifying the affected product, the labeling issue, and actions to be taken by the customer. Vistakon issued a separate Important Product Notification dated July 28, 2010 to distribuitors identifying the affected product, the labeling issue, and actions to be taken by the distributor. Customers are instructed to check their inventory for affected products and return a business reply card. If replacement -8.50 lenses are needed, the customer can contact Customer Service at 1-800-874-5178. Distributors are instructed to check their inventory for affected products and return them using an enclosed return label. Replacement product will be sent by the firm. Customer Service can be contacted at 1-800-874-5178. Accounts will be instructed to go to their inventory and look for the B006X641, -8.50 lot and open the secondary carton and verify the product inside. If it is the -9.00 product they can keep the product and re-slot it in the proper place within the kit (product is ok, nothing wrong with primary package or lens inside) and order a replacement -8.50 if necessary. Business reply cards will be supplied for accounts to return to third party indicating if they had any mix/mislabeled product.

Device

Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)
  • Model / Serial
    Lot B006X641
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.
  • Product Description
    Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) || Mislabeled Outer (secondary) Label: Lot B006X641 || D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
  • Manufacturer
    Vistakon

Manufacturer

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