Events

Recall of 1-DAY ACUVUE MOIST FOR ASTIGMATISM

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
    21522
  • Event Risk Class
    II
  • 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
    One lot of acuvue advance and one lot of 1-day acuvue moist for astigmatism contact lenses are being recalled that have been associated with complaints of a foreign matter caught between the blister package and foil. upon completion of a root cause investigation the foreign matter was identified as a bristle of a brush used for periodic cleaning as part of the manufacturing process. a limited number of bristles from the brush came off during the cleaning process and were inadvertently sealed into the packaging of the product for these occurrences. 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.

Device

1-DAY ACUVUE MOIST FOR ASTIGMATISM

Manufacturer

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