Events

Recall of ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Johnson & Johnson Vision Care, 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
    79152
  • Event Risk Class
    Class 2
  • Event Number
    Z-1209-2018
  • Event Initiated Date
    2017-10-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162499
  • 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
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • Action
    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.

Device

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
  • Model / Serial
    Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J; Vision Care Ireland
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
  • Product Description
    ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
  • Manufacturer
    Johnson & Johnson Vision Care, Inc.

Manufacturer

Johnson & Johnson Vision Care, Inc.
  • Manufacturer Address
    Johnson & Johnson Vision Care, Inc., 7500 Centurion Pkwy, Jacksonville FL 32256-0517
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA