đź“‹ FDA Reference

durasoft 2 phemfilcon a optifit toric hydrophilic contact lenses durasoft 2 phemfilcon a sherical hydrophilic c

Wesley Jessen

Summary: Durasoft 2 Phemfilcon A Optifit Toric Contact Lenses are hydrophilic lenses used to correct astigmatism. They are primarily used by optometrists and ophthalmologists for patients requiring vision correction.

FDA Clearance Information

Pathway 510K
Decision Date March 20, 2000
Product Code LPL
Device Class Class 2
Evidence 419 studies

The Durasoft 2 Phemfilcon A Optifit Toric Contact Lenses were cleared through the FDA 510(k) pathway on March 20, 2000. Manufactured by Wesley Jessen, they are classified as Class 2 medical devices.

What It Is

These are soft contact lenses made from phemfilcon A, a hydrophilic material that retains moisture and allows oxygen permeability. The toric design is specifically tailored to correct astigmatism by aligning with the natural shape of the cornea. The lenses offer comfort and clear vision for individuals with astigmatic refractive errors.

Clinical Applications

These lenses are commonly prescribed in optometry and ophthalmology practices for patients with astigmatism who prefer contact lenses over glasses. They are suitable for daily wear and can be used in various settings, including routine eye exams and vision correction consultations. The lenses cater to a wide range of patients, from teenagers to adults, seeking an alternative to spectacles.

Indications for Use

The lenses are indicated for the correction of refractive astigmatism in patients who have healthy eyes and require vision correction. They are suitable for individuals who prefer contact lenses for aesthetic or functional reasons.

Practical Considerations

These lenses are available in various sizes to fit different corneal shapes and prescriptions. Proper fitting by an eye care professional is essential to ensure comfort and effectiveness. They are compatible with most standard contact lens solutions for cleaning and storage.

Linked Studies (20)

PubMed • 2025

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

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
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

RCT|prospective|retrospective|case Series|other View Source →
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

RCT|prospective|retrospective|case Series|other View Source →
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

View Source →
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

RCT|prospective|retrospective|case Series|other View Source →
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

View Source →
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

RCT|prospective|retrospective|case Series|other View Source →
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

View Source →
PubMed • 2025

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

BioMed research international

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is Durasoft 2 Phemfilcon A Optifit Toric Contact Lenses used for?

They are used to correct astigmatism in patients who prefer contact lenses over glasses.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these lenses in their practices.

What are the FDA-cleared indications?

They are indicated for the correction of refractive astigmatism in patients with healthy eyes.

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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