Viscocel and Viscocel Plus. These products are recall
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid…
Why was Viscocel and Viscocel Plus. These products are recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots manufactured September 01, 2011 to September 19, 2013.
- 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…
- Recalling firm
- C.L.R. Medicals International, Inc.
- Quantity
- 249,592 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
- Recall date
- January 1, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)