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Bausch + Lomb ULTRA (samfilcon A) Contact Lenses - P170035

Picture of the device.

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: Bausch + Lomb ULTRA (samfilcon A) Contact Lenses
PMA Applicant: Bausch + Lomb, Inc.
Address: 1400 North Goodman Street, Rochester, NY 14609
Approval Date: April 30, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170035a.pdf

What is it? The Bausch + Lomb ULTRA is a disposable extended wear contact lens that can be worn continuously for up to six nights and seven days. The use of this contact lens requires an eye doctor's visit and prescription.

How does it work? The contact lens can bend light so it focuses on the back of the eye allowing the user to see a clear image.

When is it used? The contact lens is used to treat ametropia: near-sightedness and far-sightedness and astigmatism (blurred vision due to poor focus of light in the eye). In addition, the contact lens corrects presbyopia, an age-related condition that results in a slow loss in the ability to see things clearly close-up (e.g., while reading).

What will it accomplish? The Bausch + Lomb ULTRA contact lens may help the correction of ametropia and astigmatism. A clinical trial showed favorable vision outcomes for patients with ametropia. Approximately 97% of subject eyes in the clinical study achieved sharpness of vision with the Bausch + Lomb ULTRA (samfilcon A) contact lens. The study also demonstrates that this lens can be worn for up to 7 days with no serious adverse events and few side effects.

When should it not be used? The Bausch + Lomb ULTRA contact lens should not be used when any of the following conditions exist:

  • 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 that can trigger or worsen by wearing contact lenses or use of contact lens solutions, allergies to any ingredient in a liquid which is to be used to care for the contact lens
  • active eye infection
  • eyes become red or irritated

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available online:


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