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

  • 모델명 / 제조번호(시리얼번호)
    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, 10433000010034, 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including Puerto Rico.
  • 제품 설명
    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.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Coopervision Inc., 370 Woodcliff Dr Ste 200, Fairport NY 14450-4237
  • 제조사 모회사 (2017)
  • Source
    USFDA