FDA Device recall Z-0531-2014
Viscocel and Viscocel Plus
- FDA Device
- Class I
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class I recall of Viscocel and Viscocel Plus by C L R Medicals International, citing 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 Regulati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | C L R Medicals International |
| Distribution | US |
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.
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
Identifiers
| code_info | All lots manufactured September 01, 2011 to September 19, 2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2014%22
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