Events

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
    2010-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100823.html
  • 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
    Contact lens problems in response to media enquiries, a spokesman for the department of health (dh) said information provided by johnson & johnson (hk) limited indicated that the problem of its 1 day acuvue trueye which led to a recall of 16 batches of the product was caused by failure to remove a diluent during the rinsing process. according to johnson & johnson,the affected lots may contain lenses with trace amount of diluent agent that is intended to be extracted from the lens during the rinsing process. due to a mechanical failure in the rinsing process this extraction was not complete. this diluent agent is an intended part of the 1day acuvue trueye formulation and therefore is not considered a contaminant. in relation to the recall, the spokesman added that johnson & johnson had been asked to deploy more staff to man its enquiry hotline and speed up recall and product replacement. the spokesman said: "dh's investigation continues and the recall will be closely monitored." 20 august 2010.

Device

1 Day Acuvue TruEye
  • Model / Serial
  • Product Description
    Press release: Contact lens problems
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson