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  1. Recently-Approved Devices

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035

MiSight 1 Day Soft Contact Lenses

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
PMA Applicant: CooperVision, Inc.
Address: 5870 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: November 15, 2019
Approval Letter: Approval Order

What is it?: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are intended to slow the progression of nearsightedness in children ages 8-12. Additionally, the contact lenses are intended for vision correction of nearsightedness. The contact lenses are worn on the eye every day and discarded each day after every use. The use of this contact lens requires periodic eye doctor’s visits and a prescription.

How does it work? One part of the contact lens bends light so it focuses on the back of the eye, allowing the child to see images clearly. Another part of the contact lens bends light so it focuses in front of the back of the eye, to slow the progression of nearsigthedness over time.

When is it used? The contact lens is intended to be used in children, ages 8-12, who at the initiation of treatment have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism (low to moderate nearsightedness). This lens is used to slow the rate at which the child is becoming more nearsighted over time. The lens is also used to help a child see more clearly for things that are far away.

What will it accomplish? MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear slow the progression of nearsightedness over time. Additionally, the contact lens improves a child’s ability to see things from far away, in a way similar to glasses. In a clinical study, children who wore the contact lens over a three (3) year period did not increase their nearsightedness as much as children who wore conventional soft contact lenses, that only bends light so it focuses on the back of the eye.

When should it not be used? The contact lens should not be used in children with any of the following:

  • swelling or infection of the eye
  • eye disease, injury, or abnormality that affects the eye surface or eyelids
  • severe lack of tearing (dry eyes)
  • numbness of the eye surface
  • disease that may affect the eye or worsen by wearing contact lenses
  • allergic reactions involving the eye or the skin surrounding the eye that can be triggered or made worse by wearing contact lenses or use of contact lens solutions
  • active eye infection
  • eyes become red or irritated
  • inability to follow contact lens handling and lens wear instructions or unable to obtain assistance to do so

Additional information (including warnings, precautions, and adverse events):

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