Events

Alerte De Sécurité sur Rayner acrylic intraocular lenses

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Rayner Intraocular Lenses Limited.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1601-17
  • Numéro de l'événement
    2014DM-0002413-R1
  • Date
    2016-01-14
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=161
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    C-flex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric, Sulcoflex Aspheric and T-flex Aspheric ", specific serials.
  • Description du dispositif
    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