BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0350-2012 · Initiated November 15, 2011

    Recall

    Recall Number
    Z-0350-2012
    Event Number
    60434
    Firm
    Coopervision Inc.
    FEI Number
    1000430350
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 15, 2011
    Posted
    January 11, 2012
    Terminated
    July 24, 2018
    Address
    370 Woodcliff Dr, Ste 200, Fairport, NY, 14450-4237

    Description

    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.

    Reason

    Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.

    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

    Distribution

    Worldwide Distribution--USA (nationwide) including Puerto Rico.

    Quantity

    Domestic: approx. 3,155,781 lenses; Foreign: estimated 1,722,116 lenses