The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0531-2014·Announced 2014-01-01

C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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 Code of Federal…"

Plain-English summary

C.L.R. Medicals International, Inc. has initiated a nationwide 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 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.

The recall was initiated 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 a lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The recall covers 249,592 units of all lots manufactured between September 01, 2011, and September 19, 2013.

The products were distributed nationwide in the United States and internationally to Egypt, Mexico, and Canada. Healthcare providers and patients should contact C.L.R. Medicals International, Inc. for further instructions regarding the return or disposal of these devices.

The recalled product

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…
Manufacturer
C.L.R. Medicals International, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
249,592

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

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