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.
Enforcement
- Recall Number
- Z-0531-2014
- Event ID
- 66930
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- C.L.R. Medicals International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Press Release
- Report Date
- January 1, 2014
- Initiation Date
- November 25, 2013
- Classification Date
- December 20, 2013
- Termination Date
- December 5, 2014
- Address
- 748 E Bonita Ave Ste 210, N/A, Pomona, CA, 91767-1922, United States
Description
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.
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
All lots manufactured September 01, 2011 to September 19, 2013.
Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
249,592 units