Safety Alert for Soflens 59, lot W12010319

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

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
    2011-09-28
  • Event Country
  • Event Source
    DH
  • 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
    Medical Device Safety Alert
  • Reason
    Voluntary product recall: bausch & lomb soflens 59, lot w12010319 medical device manufacturer, bausch & lomb, is conducting a voluntary product recall for soflens 29 lot w 12010319 due to incorrect expiration date on secondary carton. 1000 units (2 packs) of soflens 59 lot w12010319, expiration date 2016-02 were repacked at the warehouse for distribution exclusively to thailand.  during the process, an overlabel with the incorrect expiration date 2106-02 was applied to the product. therefore, lenses could be expired but still be available in the supply chain due to the incorrect expiration date on the label.  according to the supplier, the affected batch is only distributed in thailand and hong kong is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bausch & Lomb Soflens 59, lot W12010319
  • Manufacturer

Manufacturer