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

FDA Recall #Z-0531-2014 — Class I — November 25, 2013

Recall #Z-0531-2014 Date: November 25, 2013 Classification: Class I Status: Terminated

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.

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

Recalling Firm

C.L.R. Medicals International, Inc. — Pomona, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

249,592 units

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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