Events

Safety Alert for Rayner acrylic intraocular lenses

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Rayner Intraocular Lenses Limited.

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
    R1601-17
  • Event Number
    2014DM-0002413-R1
  • Date
    2016-01-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=161
  • 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 that internal quality tests have revealed that the products referenced and placed on the market may contain a residual level of an auxiliary polisher used in the manufacture of the medical device, above the normal limits, leading to potentially adverse events occurring on the patients.

Device

Rayner acrylic intraocular lenses
  • Model / Serial
    C-flex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric, Sulcoflex Aspheric and T-flex Aspheric ", specific serials.
  • Product Description
    SULCOFLEX lenses are contraindicated in patients in whom safe placement in the desired area can not be achieved. The absence of the peripheral capsule is safe, the lack of intact zonules, unusual oregular anatomy of the ciliary sulcus. Warnings: the unusual oregular anatomy of the ciliary sulcus can cause a postoperative regional displacement of the bundle. In such a case the mess can be realigned or fixed by suture. An iridiotomy or iridectomy may be necessary. Precautions and warnings: check the integrity of the sterile barrier system before deusing. Do not use if the barrier system is damaged. Do not sterilize. For sole use only. The single-use intraocular lens can not be used again since it is not designed to work as intended after the first and only use. Changes in mechanic, physical and chemical characteristics under conditions of repeated use, cleaning and resterilization will compromise the integrity of the intraocular lens.
  • Manufacturer
    Rayner Intraocular Lenses Limited

Manufacturer

Rayner Intraocular Lenses Limited