AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- Coop
FDA device recall Z-0350-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Coopervision Inc.
- Reason for recall
- Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
- Action taken
- CooperVision Inc. issued a press release on November 15, 2011. An "URGENT: MEDICAL DEVICE RECALL- AVAIRA SPHERE CONTACT LENSES" letter dated November 16, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory, stop further distribution of the affected product, contact their patients and to advise their patients to check the firm's website to confirm they have the affected product. Additionally, a response form was included with the letter for customers to complete and return via fax at 866-484-1048. Contact Coopervision at 800-341-2020 for questions regarding this recall
- Root cause
- Process control
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- Domestic: approx. 3,155,781 lenses; Foreign: estimated 1,722,116 lenses
- Distribution
- Worldwide Distribution--USA (nationwide) including Puerto Rico.
- Date initiated
- 2011-11-15
- Date posted
- 2012-01-11
- Date terminated
- 2018-07-24
- Location
- Fairport, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K071736) | CooperVision, Inc. | 2008-01-04 |