Events

Recall of ACUVUE contact lens, extended-wear

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Vistakon 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
    22150
  • Event Initiated Date
    2017-10-27
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Reason
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Action
    Product to be returned to supplier

Device

ACUVUE contact lens, extended-wear
  • Model / Serial
    Model: , Affected: ACUVUE OASYS 8.8 -04.50 6P
  • Manufacturer
    Vistakon Inc

Manufacturer

Vistakon Inc