Recall Z-0350-2012 ยท LPL Lenses, Soft Contact, Daily Wear
Coopervision Inc.
AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- CooperVision: Hamble, SO31 4RF, UK -- Scottsville, NY 14546 USA -- Juana Diaz, PR 00795 USA --- Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial product 3 pack. AVAIRA (enfilcon A) SPHERE soft contact lenses are indicated for the correction of amet
| Date | Jan 11, 2012 (initiated Nov 15, 2011) |
| Status | Terminated |
| Reason | Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses. |
| Root cause | Process control |
| Action | 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 comple |
| Quantity | Domestic: approx. 3,155,781 lenses; Foreign: estimated 1,722,116 lenses |
| Distribution | Worldwide Distribution--USA (nationwide) including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc., Jan 4, 2008 |