Optimum Gp (Oxygen Permeable) Daily Wear Contact Lenses

• 2 recalls, same reason

  • Terminated Z-2982-2018 FDA Class III ·initiated 3 Jul 2018
  • Terminated Z-2981-2018 FDA Class III ·initiated 3 Jul 2018

  Vials labeled for the prescriptions contained incorrect lenses

510(k) Number

K033594 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023989 Active Cleared 26 Feb 2003

• OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K180616 Active Cleared 25 Apr 2018

• Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023987 Active Cleared 26 Feb 2003

• CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

  Class II

  FDA 510(k) K150590 Active Cleared 10 Jul 2015

• Hyper GP (tisilfocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K182304 Active Cleared 23 Nov 2018

• OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

  Class II

  FDA 510(k) K160859 Active Cleared 13 Jul 2016

See all devices from Contamac, Ltd. →