Z-0531-2014Class I

Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid...

Name: Z-0531-2014 Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid...
Creator: C.L.R. Medicals International, Inc.
Published: 2013-11-25
License: https://open.fda.gov/license/

C.L.R. Medicals International, Inc. / initiated 2013-11-25 / Terminated / root cause: manufacturing process

FDA source

C.L.R. Medicals International, Inc. began a recall of Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid... on 2013-11-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0531-2014
Classification: Class I
Status: Terminated
Initiated: 2013-11-25
Posted: 2013-12-20
Terminated: 2014-12-05
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.
Product code: LZP Aid, Surgical, Viscoelastic
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
Root cause tag: manufacturing process
FDA 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 in commerce: 249,592 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
Product codes and lots: All lots manufactured September 01, 2011 to September 19, 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0531-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0531-2014	Class I	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code LZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)