Class 1 Device Recall AVAIRA (enfilcon A) Daily Wear Sphere Contact Lens

• Date Initiated by Firm: November 15, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on July 24, 2018
• Recall Number: Z-0350-2012
• Recall Event ID: 60434
• 510(K)Number: K071736
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: 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.
• Code Information: Packaged lot numbers: 10433000002003, 10433000002503, 10433000003040, 10433000004002, 10433000004005, 10433000004504, 10433000004509, 10433000004519, 10433000004522, 10433000005005, 10433000005026, 10433000005028, 10433000005030, 10433000005507, 10433000005513, 10433000005516, 10433000005517, 10433000006005, 10433000006007, 10433000006026, 10433000006028, 10433000006030, 10433000006032, 10433000006040, 10433000006505, 10433000006510, 10433000006511, 10433000006515, 10433000006516, 10433000006517, 10433000007007, 10433000007010, 10433000007028, 10433000007030, 10433000007032, 10433000007038, 10433000007506, 10433000007508, 10433000007509, 10433000007511, 10433000007515, 10433000008004, 10433000008011, 10433000008028, 10433000008030, 10433000008032, 10433000008038, 10433000008506, 10433000008508, 10433000008512, 10433000009026, 10433000009028, 10433000009034, 10433000009036, 10433000009506, 10433000009512, 10433000010008, 10433000010016, 10433000010026, 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• Recalling Firm/ Manufacturer: Coopervision Inc.; 370 Woodcliff Dr Ste 200; Fairport NY 14450-4237
• Manufacturer Reason for Recall: Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
• FDA Determined 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 complete and return via fax at 866-484-1048. Contact Coopervision at 800-341-2020 for questions regarding this recall
• Quantity in Commerce: Domestic: approx. 3,155,781 lenses; Foreign: estimated 1,722,116 lenses
• Distribution: Worldwide Distribution--USA (nationwide) including Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LPL and Original Applicant = COOPERVISION, INC.