Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Publicado el 1 de enero de 2014 · Inicio del retiro: 25 de noviembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the Quality System Regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human
Qué hacer
Voluntary: Firm initiated · Press Release
Detalles del retiro
- Fabricante
- C.L.R. Medicals International, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
- Lote
- All lots manufactured September 01, 2011 to September 19, 2013.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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