Device Recall 1Day Acuvue Moist contact lenses for Astigmatism

  • 모델명 / 제조번호(시리얼번호)
    External carton Lot Number B00BVTN -1.50 -1.25cyl. 100¿ (30 primary packages per secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80¿ (30 primary packages per secondary carton)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: NY and FL and countries of: Finland, France, Germany, Italy, Netherlands, Norway, Denmark, Switzerland, Sweden, and the United Kingdom.
  • 제품 설명
    Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" || Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" || It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Johnson & Johnson Vision Care, Inc., 7500 Centurion Pkwy, Jacksonville FL 32256-0517
  • 제조사 모회사 (2017)
  • Source
    USFDA