Events

Safety Alert for MeniCare Soft 70ML

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

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
    2018-01-16
  • Event Date Posted
    2018-01-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180116.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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: menicon menicare soft 70ml the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning menicare soft 70ml, manufactured by menicon ltd. [affected lot numbers - (box): mp17288 and mp17350; (bottle): 703061]. according to the manufacturer, process simulation (media fill testing) in manufacturing process line was conducted and the result was failed. in regard to the manufacturing line, the manufacturer confirmed the suitability of sterility guarantee on a regular basis. as the result of last validation was passed, the manufacturer confirmed that there is no influence on the sterility of products produced until last validation. furthermore, no reports of damage to health have been received. the sterility tests performed for each manufactured lot were passed, so the possibility of any damage to health is thought to be extremely low. the manufacturer has decided to recall products manufactured after the validation as it is difficult to guarantee sterility completely. the users are advised to take the following actions:- identify and quarantine the device(s) based on the affected lot numbers if they already have used menicare soft of the affected lot numbers, the affected product should be replaced with new one. if they have symptoms like red eye, eye pain or any discomfort, they should remove lenses and contact their eye care professional. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-8-to-12-january-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 january 2018.

Device

MeniCare Soft 70ML
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Menicon MeniCare Soft 70ML
  • Manufacturer
    Menicon Ltd.

Manufacturer

Menicon Ltd.