Safety Alert for Lenscare SH- Monatslinsen contact lenses

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by 4Care AG.

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.

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  • Type of Event
    Safety alert
  • Date
  • Event Country
  • Event Source
  • 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
    Safety alert over lenscare sh- monatslinsen contact lenses the department of health (dh) today (december 7) drew public attention to the recall of certain lots of lenscare sh-system monatslinsen contact lenses because of the presence of small parts of silicone oil on the lenses. a dh spokesman revealed that the department, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency (mhra) had issued a notice about the recall by the manufacturer, 4care ag, based in germany. according to the manufacturer, they were informed by their production plant that silicone oil was found on certain lots of the contact lenses. this may lead to blurred vision, foreign body sensation or eye pain and so far, they did not receive complaints related to the incident. the lot numbers of the affected products are – 104350000200060215 104350000180050115 104350000120300115 104350000190090215 104350000210090215 104350000210050415 104350000190090215 104350000200100315 104350000240060315 104350000160220215 104350000200100315 104350000260080515 104350000110300115 104350000210140315 104350000250130315 104350000200060215 104350000170220315 104350000200190315 104350000190090215 104350000140230315 104350000140210415 104350000015190315 104350500000281114 104350000035180315 "the dh has immediately contacted the manufacturer in germany and found that the affected products have not been distributed in hong kong. although the affected products are not marketed in hong kong and we have no record of related adverse events here, the fact that there may be occasional users in the territory who have somehow obtained the devices from abroad justify a public alert, in our opinion," the spokesman said. "those customers who have used the said product and are either feeling unwell or in doubt should consult their healthcare professionals for advice as soon as possible.” the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. the spokesman added, "dh is aware that the use of contact lenses, including decorative lenses, is becoming increasingly common amongst the public. as the improper use of these lenses could seriously damage eye health, we would like to take this opportunity to remind members of the public on the proper use of contact lenses, especially as the festive season is drawing close and they may wear these lenses to parties or other social functions. before buying these lenses, consumers ought to consult their healthcare professionals. remove the contact lenses whenever you experience discomfort or redness of the eyes and seek advice from healthcare professionals promptly if symptoms persist. " ends.


  • Model / Serial
  • Product Description
    Press release: Safety alert over Lenscare SH- Monatslinsen contact lenses
  • Manufacturer


  • Source