Reported Jan 1, 2014 · Terminated
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be…
C.L.R. Medicals International, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.L.R. Medicals International, Inc. · 748 E Bonita Ave Ste 210 · Pomona, CA · 91767-1922
Is this the product you have?
- 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.
- Lot codes and dates
All lots manufactured September 012011 to September 192013
- Amount recalled
- 249,592 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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