Important Safety Alerts

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