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 ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
FDA Recall Z-0350-2012 · Posted 2012-01-11
Recalling FirmCoopervision Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2011-11-15
Date Terminated2018-07-24
Product QuantityDomestic: approx. 3,155,781 lenses; Foreign: estimated 1,722,116 lenses
Reason for Recall
Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
Firm 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 complete and return via fax at 866-484-1048. Contact Coopervision at 800-341-2020 for questions regarding this recall
Root Cause
Process control
Distribution Pattern
Worldwide Distribution--USA (nationwide) including Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.