Vistakon (Senofilcon a) Soft Contact Lens

• • Terminated Z-1131-2019 FDA Class II ·initiated 11 Mar 2019

  One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.

• • Terminated Z-1744-2020 FDA Class II ·initiated 18 Dec 2017 ·on shared 510(k) K042275

  Package integrity failure observed during routine shift package integrity testing at an external re-packager.

• • Terminated Z-1209-2018 FDA Class II ·initiated 19 Oct 2017 ·on shared 510(k) K042275

  Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K042275 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted (Visibility and/or Cosmetic) with UV Bloc

  Class II

  FDA 510(k) K013973 Active Cleared 26 Feb 2002

• Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker

  Class II

  FDA 510(k) K033969 Active Cleared 4 Feb 2004

• Vistakon (Hefilcon C) Contact Lenses

  Class II

  FDA 510(k) K010218 Active Cleared 16 Mar 2001

• Vistakon (Methafilcon a) Contact Lenses

  Class II

  FDA 510(k) K010507 Active Cleared 12 Apr 2001