CLASS II Device recall · Reported 9 Jan 2013 · FDA Enforcement Report
Avaira (enfilcon A) Soft (Hydrophilic) Daily Wear Toric recalled
Cooper Vision Caribbean is recalling Avaira (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses, distributed nationwide in the US. The recall was initiated on 9 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0631-2013
- FDA event ID
- 63719
- Recalling firm
- Cooper Vision Caribbean, Juana Diaz, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2012
- FDA classified
- 3 Jan 2013
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 9 Nov 2012 | Recall initiated by company | |
| 3 Jan 2013 | Classified by FDA | +55 days |
| 9 Jan 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The lenses exceeded the acceptance limit for silicone oil residual.
Product as listed by the FDA
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Where it was distributed
US Nationwide, including Puerto Rico, and Canada.
Questions about this recall
Why was it recalled?
The lenses exceeded the acceptance limit for silicone oil residual.
Which lots are affected?
10447500016006, 10519550007006, 10537500016014
Where was it sold?
US Nationwide, including Puerto Rico, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cooper Vision Caribbean
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Soft Contact Lens recalled by Cooper Vision Caribbean | Cooper Vision Caribbean | Other | Nationwide |
| Device | CLASS III | ProClear Toric contact lenses are made from a material recalled | Cooper Vision Caribbean | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |