Events

Recall of ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON 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
    31258
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Johnson & johnson vision care inc. (jjvc) is voluntarily recalling in canada two lots of acuvue oasys for astigmatism contact lenses because of quality concerns. two lots of acuvue oasys for astigmatism contact lenses that are being recalled have been associated with a limited number of confirmed reports of visual acuity being 'off power' which the consumer may recognize as not accurately correcting the vision in one eye (some distortion or blurriness).Upon investigation it was determined that inserts within the mold used for manufacturing were damaged when making the front and back curve molds of the contact lens. jjvc has implemented improved inspection techniques for the identification of damaged inserts within the mold. to date no patient injuries related to this issue have been reported. no customer complaints related to this recall were reported in canada.

Device

ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

Manufacturer

JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON INC.