Viscocel and Viscocel Plus — Class I medical device recall Z-0531-2014
Terminated recall by C.L.R. Medicals International, Inc., reported 2014-01-01, distributed nationwide. CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to F
| Recall number | Z-0531-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.L.R. Medicals International, Inc., Pomona, CA, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, EG, MX |
| Quantity | 249,592 units |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0531-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.