Safety Alert for 1 Day Acuvue TruEye

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Johnson & Johnson.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2010-08-19
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Voluntary recall of single-use contact lenses the department of health (dh) was notified by johnson & johnson (hk) limited today (august 19) that a voluntary recall of 16 batches of contact lens 1 day acuvue trueye is underway due to potential eye irritation or discomfort as a result of using the product. a dh spokesman said the affected batch was manufactured in ireland with lot numbers - 492237, 492238, 492241, 492245, 492250, 492251, 492252, 492254, 492268, 492280, 492281, 492282, 492283, 492287, 492288 and 492289. these numbers are the first six digits of the lot number printed at the side of the product box. according to johnson & johnson, the recall followed complaints regarding "unusual stinging or pain upon inserting of lens" reported in japan, which included stinging, ocular pain, redness and irritation. the investigation of the manufacturer so far showed that there was a problem in one portion of the lens rinsing process on a particular manufacturing line during a certain period of time. in hong kong, there has so far been no reported adverse events arising from use of the affected batches. according to the local supplier, about 3,715 boxes of the affected batches have been shipped out to optical outlets. the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2963 6799, for recall and product replacement. the hotline will operate from august 20 until september 22, daily between 9am and 6pm. the recall details can also be accessed at the website: www.Acuvue.Com.Hk. those who feel unwell after using the product should seek advice from their healthcare professionals. meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue. the recall will be closely monitored. ends/thursday, august 19, 2010.

Device

  • Model / Serial
  • Product Description
    Press release: Contact lens problems
  • Manufacturer

Manufacturer