Events

Field Safety Notices about ACUVUE® OASYS® for ASTIGMATISM

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Johnson & Johnson Vision Care, Inc. .

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
  • Date
    2017-10-26
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The series number for acuvue® oasys® for astigmatism® contact lenses is indicated on the individual contact lens blister pack and for the six units, also in the bar code area on the back of each package.   jjvc has opted for voluntary recall in order to provide customers with the highest quality products. we received a number of confirmed reports of a "malfunctioning" lens, which was perceived by users as inaccurate vision correction in one eye (distorted or blurred vision). following the investigation, it was found that the inserts in the mold used for the manufacture were damaged in the manufacture of molds for the front and rear curves of the contact lenses. jjvc has introduced enhanced control over techniques for identifying damaged mold inserts. not all the lenses of the aforementioned series are damaged and the case poses no significant health risks.

Device

ACUVUE® OASYS® for ASTIGMATISM

Manufacturer

Johnson & Johnson Vision Care, Inc.