Food, drugs, devices › Cooper Vision Caribbean Corp.
Device recall: ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2
FDA enforcement event 69160 is a device recall by Cooper Vision Caribbean Corp. of Juana Diaz, PR, initiated 17 Sep 2014 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 10 Jun 2015. Initiation: voluntary: firm initiated. Cooper Vision Caribbean Corp. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cooper Vision Caribbean Corp., Juana Diaz, PR.
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."
Distribution
"Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0134-2015 | 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. | 13639 lenses/246 product lots | Class III | Terminated | 5 Nov 2014 |
Context
Other enforcement events for Cooper Vision Caribbean Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Oct 2014 | Soft Contact Lens | Device | Class II | 1 |
| 9 Nov 2012 | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | Device | Class II | 1 |
All 3 events for Cooper Vision Caribbean Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.