Events

Safety Alert for Soft Contact Lenses Hydrated

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia 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
  • Event ID
    R1801-50
  • Event Number
    2008DM-0002061
  • Date
    2018-01-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=59
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected cases of visual acuity complaints with the referenced devices, the measurement analysis of the lens parameters (diopter, cylinder, shaft) were out of specification, because of the mold damage during its manufacture, this situation could lead to that possible adverse events occur on patients.

Device

Soft Contact Lenses Hydrated
  • Model / Serial
    ACUVUE OASYS, lot B00GW4Z, B00HRMG, serial 83077, 84284.
  • Product Description
    They are indicated for daily use and prolonged use, for correction of myopia, hyperopia associated with astigmatism, UV filter.
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care