Acryflex SC60B-0UV 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-acryflex-sc60b-0uv-societe-medical-developmental-research

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 three reports of materiovigilance received between 26 September 1999 and 7 February 2000. Seen. the expert report of 8 February 2000. Seen. Mail No. 20000822 dated March 1, 2000, sent to the manufacturer for comments. Considering. that the reports of materiovigilance report four opacifications of Acryflex SC60B-0UV intraocular lenses manufactured and put on the market by the company Medical Developmental Research from December 3, 1997 to March 17, 1999, occurred within 12 to 24 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 a lens, and that this operation puts patients at risk. Considering. whereas it is therefore appropriate, pending the determination of the causes of the opacifications and in the interest of public health, to suspend the implantation of these lenses. DECIDE. ARTICLE 1. : The distribution, importation and use of Acryflex SC60B-0UV intraocular lenses manufactured by Medical Developmental Research - 2451 Enterprise Road - Clearwater - Florida 33763 - USA, is suspended for a period of 6 months, starting at the date of publication of this Decision. ARTICLE 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. Dated at Saint-Denis on April 10, 2000.