The Recall Desk

FDA (Devices) recall action 64468

Johnson & Johnson Vision Care, Inc. recalled 2 products on 2013-05-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-05-22
Critical
0
Units
39,876

Why these products were recalled

Limited number of individual contact lens packages may not have been completely sealed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2013-05-22

    ACUVUE ADVANCE Contact Lenses Recalled for Incomplete Sealing

    Johnson & Johnson Vision Care is recalling ACUVUE ADVANCE contact lenses because a limited number of packages may not have been completely sealed.

    Product
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2013-05-22

    Johnson & Johnson Recalls 1-DAY ACUVUE MOIST Contact Lenses for Sealing Defects

    Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE MOIST contact lenses because some packages may not be completely sealed.

    Product
    1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance…
    Category
    Distribution
    31 states