📋 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 ?
510(k)
Number ?
K000439 ↗
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.
FDA-Cleared Indications
- Correction of refractive astigmatism.
- Use in patients with healthy eyes who require vision correction.
- Daily-wear contact lens use as prescribed and fitted by an eye-care professional.
Clinical Applications
- Vision correction for patients with astigmatism.
- Daily-wear contact lens correction as an alternative to eyeglasses.
- Use following professional fitting and prescription by an optometrist or ophthalmologist.
Practical Considerations
- A toric lens must be properly fitted and oriented on the eye to provide stable astigmatism correction.
- Available parameters and sizes should be matched to the patient's prescription and corneal shape by an eye-care professional.
- Follow the prescribed cleaning, disinfection, storage and replacement schedule; use only compatible contact-lens solutions.
- Do not wear lenses with eye infection, significant irritation or other contraindications identified by an eye-care professional.
- Contact lenses are not relevant to MRI safety because they are worn on the eye and are not implanted or used during an imaging procedure; they may be removed if requested by the imaging facility.
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
RCT|prospective|retrospective|case Series|other View Source →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
View Source →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
View Source →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
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.