Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 5, 2014
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cooper Vision Caribbean Corp. recalled ProClear Toric contact lenses are made from a material containing 62% water and 3… - a low-severity action.
ProClear Toric contact lenses are made from a material containing 62% water and 3… was recalled by Cooper Vision Caribbean Corp. in November 5, 2014. Reason: Routine quality monitoring system has identified that a limited number of lots were manufactured with the cy…. Check the official notice for the remedy. Verify recall #Z-0134-2015 with the FDA Devices before acting.
The recall
Cooper Vision Caribbean Corp. issued this low-severity FDA Devices recall-Routine quality monitoring system has identified that a limited number of lots were manufactured with the cy….
- Low
- severity level
- Class III
- classification
- November 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0134-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0134-2015) was formally reported on November 5, 2014, with the manufacturer initiating the action on September 17, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Cooper Vision Caribbean Corp. is listed as the recalling firm, operating out of Juana Diaz, PR. Federal records list the affected scope as 13639 lenses/246 product lots.
The documented reason for this recall is: Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13639 lenses/246 product lots
Related Recalls
6
3 from same agency
Product description
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
Reason for recall
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0134-2015 |
| Date reported | November 5, 2014 |
| Date initiated | September 17, 2014 |
| Recalling firm | Cooper Vision Caribbean Corp. |
| Firm location | Juana Diaz, PR |
| Affected scope | 13639 lenses/246 product lots |
| Distribution | Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries. |
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-0134-2015) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.. Recalled by Cooper Vision Caribbean Corp.. Units affected: 13639 lenses/246 product lots.
Why was this product recalled? ▼
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Low. Recall number: Z-0134-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0134-2015) 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 November 5, 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.