Food, drugs, devices › Cooper Vision Caribbean Corp.
Device recall: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
FDA enforcement event 63719 is a device recall by Cooper Vision Caribbean Corp. of Juana Diaz, PR, initiated 9 Nov 2012 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 9 May 2014. 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
"The lenses exceeded the acceptance limit for silicone oil residual."
Distribution
"US Nationwide, including Puerto Rico, and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0631-2013 | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | 246 | Class II | Terminated | 9 Jan 2013 |
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 |
| 17 Sep 2014 | ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2 | Device | Class III | 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: "The lenses exceeded the acceptance limit for silicone oil residual."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide, including Puerto Rico, and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 May 2014. "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.