đź“‹ FDA Reference

apioc efrofilcon a soft hydrophilic silicone hydrogel contact lens apioc p for presbyopia efrofilcon a soft hydrophilic silicone hydrogel contact lens apioc a for astigmatism efrofilcon a soft hydrophilic silicone hydrogel contact lens apioc ap efrofilcon a soft hydrophilic silicone hydrogel contact lens

Lentechs

Summary: The apioc efrofilcon a lenses are soft hydrophilic silicone hydrogel contact lenses designed for presbyopia and astigmatism. They are used by eye care professionals to correct vision in patients with these conditions.

FDA Clearance Information

Pathway 510K
Decision Date September 6, 2019
Product Code LPL
Device Class Class 2
Evidence 419 studies

The apioc efrofilcon a contact lenses were cleared via the FDA 510k pathway on September 6, 2019. Manufactured by Lentechs, they are classified as Class 2 medical devices.

What It Is

The apioc efrofilcon a lenses are advanced contact lenses made from a silicone hydrogel material, which allows for high oxygen permeability. This makes them comfortable for extended wear. They are designed to correct refractive errors such as presbyopia and astigmatism, providing clear vision for patients with these conditions.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology settings, particularly for patients who require correction for presbyopia or astigmatism. They are suitable for adults who prefer contact lenses over glasses for vision correction. Eye care specialists may prescribe these lenses during routine eye exams or when patients report difficulties with near or distance vision.

Indications for Use

The lenses are indicated for patients with presbyopia, a condition where the eye gradually loses the ability to focus on nearby objects, and for astigmatism, which causes blurred vision due to an irregularly shaped cornea.

Practical Considerations

These lenses are available in various sizes to fit different eye shapes and prescriptions. They are compatible with standard contact lens care solutions. Proper fitting by an eye care professional is essential to ensure comfort and optimal vision correction.

Related Literature

The linked study focused on evaluating the acceptance of toric soft contact lenses in patients with low astigmatism. It compared custom toric lenses to spherical off-the-shelf lenses, assessing both objective and subjective visual performance. The study found that custom toric lenses provided better visual outcomes for these patients. However, the study was limited by its focus on a specific population and did not address long-term outcomes.

Linked Studies (20)

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Frequently Asked Questions

What is apioc efrofilcon a used for?

These lenses are used to correct vision in patients with presbyopia and astigmatism.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these lenses in their practice.

What are the FDA-cleared indications?

The lenses are indicated for correcting presbyopia and astigmatism in patients.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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