AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
FDA device recall Z-0631-2013 · posted 2013-01-03 · Terminated
Recall details
- Recalling firm
- Cooper Vision Caribbean Corp.
- Reason for recall
- The lenses exceeded the acceptance limit for silicone oil residual.
- Action taken
- The recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 246
- Distribution
- US Nationwide, including Puerto Rico, and Canada.
- Date initiated
- 2012-11-09
- Date posted
- 2013-01-03
- Date terminated
- 2014-05-09
- Location
- Juana Diaz, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AVAIRA (ENFILCON A) CONTACT LENS (K113759) | CooperVision, Inc. | 2012-04-03 |