📋 FDA Reference
Sunsoft Methafilcon a Soft Hydrophilic Daily Wear Contact Lens
Sunsoft
Summary: The Sunsoft Methafilcon A is a soft hydrophilic contact lens for daily wear, used primarily for vision correction. It is typically used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K964696 ↗
Decision Date ?
February 20, 1997
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Sunsoft Methafilcon A Soft Lens was cleared through the FDA 510(k) pathway on February 20, 1997. It is manufactured by Sunsoft and classified as a Class 2 medical device.
What It Is
The Sunsoft Methafilcon A is a soft contact lens made from a hydrophilic material, designed for daily wear. It works by conforming to the shape of the eye, providing comfort and clear vision. The lens is designed to correct refractive errors such as myopia and hyperopia, offering an alternative to glasses.
FDA-Cleared Indications
- Daily-wear vision correction with a soft hydrophilic contact lens.
- Correction of refractive errors, including myopia and hyperopia, when prescribed and fitted by an eye-care professional.
Clinical Applications
- Correcting nearsightedness with a prescribed contact-lens power.
- Correcting farsightedness with a prescribed contact-lens power.
- Providing a daily-wear alternative to eyeglasses.
- Use in outpatient optometry or ophthalmology care after professional fitting.
Practical Considerations
- The lens must be fitted and prescribed by an optometrist or ophthalmologist; available parameters may include different powers, base curves, and diameters.
- Follow the product-specific instructions for insertion, removal, cleaning, disinfection, replacement, and storage. Do not share lenses or use tap water or saliva for lens care.
- Daily-wear lenses are generally removed before sleeping unless the specific labeling and eye-care professional authorize otherwise.
- Patients with active eye infection, significant ocular irritation, or conditions that make contact-lens wear unsafe may need to avoid or stop use and seek eye-care advice.
- Contact lenses are not an implanted device and do not present an MRI-device safety issue; they should be removed if required by the MRI facility or if they contain components that the facility considers unsuitable.
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 Sunsoft Methafilcon A Soft Lens used for?
It is used for correcting refractive errors such as myopia and hyperopia, providing clear vision as an alternative to glasses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in clinical practice for vision correction.
What are the FDA-cleared indications?
The lenses are indicated for daily wear to correct refractive errors like nearsightedness and farsightedness.
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.