Events

Safety Alert for Hydrophobic Monofocal Lens with Injector BIOTECH

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biotech Vision Care Pvt. Ltd..

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
    I1701-22
  • Event Number
    2013DM-0010831
  • Date
    2017-01-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=105
  • 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 the possibility of finding particles in the referenced device that do not come from the lens of the injector, although they are not toxic nor represent a danger to the patient, but they can lead to delays in the surgical procedures.

Device

Hydrophobic Monofocal Lens with Injector BIOTECH
  • Model / Serial
  • Product Description
    It is a high precision optical device, manufactured by machining. These lenses and tension rings are designed to be surgically implanted in the human eye as a replacement for the lens. The extraction of the natural or crystalline lens can be done with any of the existing techniques, manually (extracapsular) or by phacoemulsification.
  • Manufacturer
    Biotech Vision Care Pvt. Ltd.

Manufacturer

Biotech Vision Care Pvt. Ltd.
  • Source
    NIDFSINVIMA