Recall Z-0531-2014 ยท LZP Aid, Surgical, Viscoelastic
C.L.R. Medicals International, Inc.
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.
| Date | Dec 20, 2013 (initiated Nov 25, 2013) |
| Status | Terminated |
| 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 |
| Root cause | No Marketing Application |
| Action | CLR Medicals initiated a nationwide recall on November 25, 2013, of Viscocel and Viscocel Plus, by issuing a press release,in response to FDA inspectional 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 and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the pro |
| Quantity | 249,592 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.