Orion IFP3D6 의 리콜

Recall

2000-04-10

France

ANSM

https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/lentilles-intra-oculaires-orion-ifp3d6--eurocrystal

The director general. Vu. Book VIII of the Public Health Code, and in particular Articles L.793-1 and L.793-5-I. Vu. the eight reports of materiovigilance received between October 26, 1999 and February 28, 2000. Seen. the expert report of 8 February 2000. Seen. Mail No. 20000823 dated March 1, 2000, sent to the manufacturer for comments. Considering. that the reports of materiovigilance report nine opacifications of intraocular lenses Orion IFP3D6 manufactured, put on the market and distributed by the company Eurocrystal from March 17, 1999, intervened within 3 to 22 months after their implantation. Considering. to date, the origin of these opacifications, which have led to a decrease in the visual acuity of the patients, could not be determined. Considering. that these opacifications required the explantation of six lenses, and that this operation puts patients at risk. Considering. whereas, therefore, pending the determination of the causes of the opacifications and in the interest of public health, the implantation of these lenses should be suspended. DECIDE. ARTICLE 1e. : The manufacture, placing on the market, distribution, export and use of Orion IFP3D6 intraocular lenses manufactured by Eurocrystal - 3, avenue de l'Europe - Campus 2A - 31400 TOULOUSE, are suspended for a period of six months from the date of publication of this Decision. The Director of Medical Device Evaluation and the Director of Inspection and Facilities are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Done at Saint-Denis, April 10, 2000.