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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The source text cites regulatory and quality system deficiencies rather than reported injuries or specific product defects causing harm.
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 tr
- Manufacturer
- C.L.R. Medicals International, Inc.
- Category
- Medical Device — Ophthalmic
- 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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