Drug recall
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid…
FDA recall event 66930 · Class I · C.L.R. Medicals International, Inc.
Key facts
| Event ID | 66930 |
|---|---|
| Recall numbers | Z-0531-2014 |
| Recalling firm | C.L.R. Medicals International, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 25, 2013 |
| Report date | Jan 1, 2014 |
| Termination date | Dec 5, 2014 |
| City | Pomona |
| State | CA |
| Country | United States |
| FEI number | 3004172696 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: