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.

Recall number

Z-0531-2014

Recalling firm

C.L.R. Medicals International, Inc.

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.

Status

Terminated

Initiated

2013-11-25

Posted

2013-12-20

Terminated

2014-12-05

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 product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products. CLR Medicals International, Inc. sent a Medical Device Recall letter dated December 6, 2013, to all affected customers. The letter informed customers of the reason for recall, product description with manufacturing date range, possible health hazard, instructions on what to do with recalled product, and contact information for the firm and to report any adverse events to FDA MedWatch. The recall notification letter was accompanied by a response form. Customers with questions were instructed to call 909-398-1880. For questions regarding this recall call 909-398-1880.

Quantity

249,592 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LZP

Firm FEI

3004172696

Firm city

Pomona

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy