Events

Safety Alert for ACUVUE®OASYS® with HYDRACLEAR® Plus Contact Lenses

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

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
    2012-01-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120111.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
    Recall of selected lots of contact lenses the department of health (dh) today (january 10) drew public attention to the recall of three lots of contact lenses - acuvue®oasys® with hydraclear® plus contact lenses - because the affected products were found to have higher than expected levels of a diluting agent which could affect lens performance due to reduced wettability. 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 had posted a recall notice issued by the manufacturer, johnson & johnson vision care. according to the manufacturer, the problem was due to an isolated interruption in the lens rinsing process on one manufacturing line and the cause has already been rectified. the manufacturer reported no consumer complaints or adverse events so far, and advised that while wearers of the affected lenses may experience some eye discomfort or eye redness upon lens insertion, long-term health consequences are highly unlikely. "the dh has immediately contacted the product's local supplier and found that the affected lots have not been distributed in hong kong. although the three lots under recall are not distributed 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 affected products from abroad justify a public alert," the spokesman added. details of the affected products (8.8 base curve) are listed below. consumers are advised to check the printed lot number reading from left to right on the outer package and on each individual contact lens container to identify the affected products. lot number power l001rj5 -2.00d l001rj8 -2.75d l001rj9 -3.00d "those customers who have used the said products 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. ends.

Device

ACUVUE®OASYS® with HYDRACLEAR® Plus Contact Lenses
  • Model / Serial
  • Product Description
    Press release: Recall of selected lots of ACUVUE® OASYS® with HYDRACLEAR® Plus Contact Lenses
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care