FDA-Device2014-01-01Class I
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.
C.L.R. Medicals International, Inc.
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
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
Affected count
249,592 units
Manufactured in
748 E Bonita Ave Ste 210, N/A, Pomona, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2014Don't want to check this manually?
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