đź“‹ FDA Reference

hydrasoft east and hydrasoft toric east methafilcon b daily wear soft hydrophilic contact lens

Coopervision

Summary: Hydrasoft East and Hydrasoft Toric East are daily wear soft hydrophilic contact lenses by Coopervision, designed for vision correction in patients with refractive errors. They are primarily used by optometrists and ophthalmologists.

FDA Clearance Information

Pathway 510K
Decision Date December 17, 1996
Product Code LPL
Device Class Class 2
Evidence 419 studies

These contact lenses were cleared through the FDA 510(k) pathway on December 17, 1996. Manufactured by Coopervision, they are classified as Class 2 medical devices under product code LPL.

What It Is

The Hydrasoft East and Hydrasoft Toric East are soft contact lenses made from methafilcon B, a hydrophilic material that allows for comfortable daily wear. These lenses are designed to correct refractive errors such as myopia, hyperopia, and astigmatism, providing clear vision by focusing light directly on the retina. The toric version is specifically tailored for patients with astigmatism, offering a stable and precise fit.

Clinical Applications

These contact lenses are commonly used in optometry and ophthalmology practices for patients requiring vision correction. They are suitable for individuals with myopia, hyperopia, and astigmatism, and are often prescribed during routine eye exams. The lenses are ideal for patients seeking a comfortable and convenient alternative to glasses, especially those with active lifestyles.

Indications for Use

The FDA indications suggest these lenses are intended for daily wear to correct refractive errors such as nearsightedness, farsightedness, and astigmatism. They are suitable for patients who prefer contact lenses over glasses for vision correction.

Practical Considerations

These lenses are available in a range of powers to accommodate various levels of refractive error. It's important to ensure proper fitting and handling techniques to maximize comfort and visual acuity. Regular follow-up with an eye care professional is recommended to monitor eye health and lens performance.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

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PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

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PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

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PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

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PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

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PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

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PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

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PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

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PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

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PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

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Frequently Asked Questions

What is Hydrasoft East and Toric East used for?

These lenses are used for correcting refractive errors such as myopia, hyperopia, and astigmatism.

What specialties typically use this device?

Optometrists and ophthalmologists typically prescribe these lenses during routine eye exams.

What are the FDA-cleared indications?

These lenses are indicated for daily wear to correct vision in patients with nearsightedness, farsightedness, and astigmatism.

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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