FDAFDA · Food and drugs·Recall number Z-0531-2014
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.
Published January 1, 2014 · Recall initiated: November 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- C.L.R. Medicals International, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
- Lot
- All lots manufactured September 01, 2011 to September 19, 2013.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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