Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 1, 2014
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.
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 Regulati…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
C.l.r. Medicals International, Inc. recalled Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of… - a critical-severity action.
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of… was recalled by C.l.r. Medicals International, Inc. in January 1, 2014. Reason: CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to …. Check the official notice for the remedy. Verify recall #Z-0531-2014 with the FDA Devices before acting.
The recall
C.l.r. Medicals International, Inc. issued this critical-severity FDA Devices recall-CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to ….
- Critical
- severity level
- 250K units
- affected scope
- Class I
- classification
- January 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0531-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0531-2014) was formally reported on January 1, 2014, with the manufacturer initiating the action on November 25, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. C.l.r. Medicals International, Inc. is listed as the recalling firm, operating out of Pomona, CA. Federal records list the affected scope as 249,592 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
249,592 units
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0531-2014 |
| Date reported | January 1, 2014 |
| Date initiated | November 25, 2013 |
| Recalling firm | C.l.r. Medicals International, Inc. |
| Firm location | Pomona, CA |
| Affected scope | 249,592 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0531-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by C.l.r. Medicals International, Inc.. Units affected: 249,592 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Critical. Recall number: Z-0531-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0531-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 1, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.