Events

Safety Alert for Soft Contact Lenses

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Coopervision Inc. (Ocular Sciences).

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
    R1501-20
  • Event Number
    2007DM-0001254
  • Date
    2015-01-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the aforementioned medical devices may present problems because they contain lenses with an incorrect objective axis, which can cause blurred vision, leading to the generation of possible adverse events on the patient.

Device

Soft Contact Lenses
  • Model / Serial
    Biomedics Toric, lots 8246525202 and 8255525096.
  • Product Description
    Soft contact lenses for extended use, programmed replacement OCUFILCON D SPHERE, ASPHERE and TORICO.BIOMEDICS 55 SPHERE UV PROTECTION AND EDGE III 55 are indicated for the correction of visual acuity in nonfaithful persons, without eye diseases, which manifest myopia, hyperopia and astigmatism. BIOMEDICS ASPHERE with UV protection are indicated for the correction of visual acuity in non-Afacic people, without diseases in the eyes and have been aspherised to control the longitudinal aberration of the lenses through the range of power. BIOMEDICS TORIC with UV protection are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-apothecary people without eye diseases.
  • Manufacturer
    Coopervision Inc. (Ocular Sciences)

Manufacturer

Coopervision Inc. (Ocular Sciences)