Events

Recall of Various Acuvue for Astigmatism Contact Lenses

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Pacific Pty Ltd.

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
    RC-2017-RN-01377-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01377-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Johnson & johnson vision care (jjvc) has identified quality issues identified with specific batches of acuvue contact lenses. a limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”. foreign matter - a limited number of reports of a brush bristle found between the blister package and foil have been received.Off power - a limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). not all lenses in these lots are affected and there is no significant health risk related to this issue.To date, there have been no adverse events related to these issues.
  • Action
    Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.

Device

Various Acuvue for Astigmatism Contact Lenses
  • Model / Serial
    Various Acuvue for Astigmatism Contact LensesAcuvue Oasys for Astigmatism, 8.6 -6.00 -1.75/170 6P and 8.6 -3.50 -0.75/180 6PLot Numbers: B00GW4Z and B00HRMGExpiry: Nov 2018 and Jul 2019Acuvue Oasys, 8.8 -04.00 6P RXLot: L002NCSExpiry: May 2020Acuvue Oasys, 8.8 -04.50 6PLot: L002QH9Expiry: Aug 20201 Day Acuvue Moist for Astigmatism, 8.5 -7.50 -1.25/180 90PLot: F00LF41Expiry: Apr 2021ARTG Numbers: 223534, 223535, 223536 and 154490
  • Manufacturer
    Johnson & Johnson Pacific Pty Ltd

Manufacturer

Johnson & Johnson Pacific Pty Ltd