C.L.R. Medicals International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0531-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: November 25, 2013

Date Posted: January 1, 2014

Recall Number: Z-0531-2014

Event ID: 66930

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

Status: Terminated

Product Quantity: 249,592 units

Code Information:

All lots manufactured September 01, 2011 to September 19, 2013.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated