Events

Alerte De Sécurité sur Aqua-sense intraocular lens manufactured by Ophthalmic Innovations International Inc. (OII Inc.) distributed in the United Kingdom between December 1, 1999 and November 15, 2000. These lenses can be identified by serial numbers with order 00003-XXXX to 00313-XXXX.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par OPHTHALMIC INNOVATIONS INTERNATIONAL INC..

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
    777
  • Date
    2004-04-05
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The latest notification by the manufacturer indicates that of the 868 lenses implanted in the United Kingdom, 233 (27%) were explanted due to opacification. The Medicines and Healthcare Products Regulatory Agency - MHRA has established direct communication with specialized professionals who agree to the actions listed above as being the most appropriate.
  • Cause
    Ophthalmic innovations international inc. (oii inc.) has issued a letter addressed to uk health professionals in may 2001 informing their clients of an increased incidence of opacification with the aqua-sense intraocular lens and recommending that monitor their patients in the postoperative period. while the cause of opacification is multi-factorial, studies conducted by the manufacturer indicate that surface calcification appears to be linked to the migration of silicone from the package onto the surface of the lens. no lens has been supplied to the uk since november 2000.
  • Action
    1) Identify patients implanted with these lenses; 2) Consider contacts with these patients to alert them to a review visit if they are experiencing an opacified vision; 3) Ensure that all patients who have been implanted with affected lenses are aware that they must undergo a review visit if their vision deteriorates in the future; 4) Report all incidents of manufacturer-independent opaque intraocular lens to the Surveillance Unit - UTVIG / GGTPS / ANVISA and its lens manufacturer; 5) Watch out if the UTVIG Technovigilance Unit will publish further information on the Hydroviem IOL opacification incident.

Device

Aqua-sense intraocular lens manufactured by Ophthalmic Innovations International Inc. (OII Inc.) ...

Manufacturer

OPHTHALMIC INNOVATIONS INTERNATIONAL INC.
  • Source
    ANVSANVISA