Device product
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.
Z-0531-2014
Product summary
- Event
- Event 66930
- Status
- Terminated
- Classification
- Class I
- Quantity
- 249,592 units
- Official record key
device-enforcement:Z-0531-2014
Official wording
Reason: 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
Code information: All lots manufactured September 01, 2011 to September 19, 2013.
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
Derived failure modes
-
Unknown
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