Field Safety Notices about Proclear toric contact lenses

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by CooperVision, England.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 recall data from the U.S. and Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received from a medical device manufacturer CooperVision, England, a notification on the recall of the medical device Proclear toric contact lenses.
    The manufacturer has discovered by its own quality system that a limited number of batches is minimally produced out of specification and therefore decides to voluntary recall the product from the market.
    Taking account that there is no risk for users, the recall of the batches 100375500080080717, 104235500040220516 and 104275000160220117 is being carried out at the retail level. According to manufacturer’s records, 4 packs with 6 contact lenses each, have been delivered to the Republic of Croatia.