Recall Z-0531-2014— C.L.R. Medicals International, Inc.

Class I FDA medical device recall by C.L.R. Medicals International, Inc., initiated 2013-11-25, terminated 2014-12-05. FDA's recall record names no specific 510(k) clearance for this event. 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.

Recalling firm

C.L.R. Medicals International, Inc.

Classification

Class I

Status

Terminated

Initiated

2013-11-25

Terminated

2014-12-05

Firm location

Pomona, CA, United States

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