đź“‹ FDA Reference
polyvue silver chord and unisoft methafilcon a spherical aspherical toric and multifocal hydrophilic contact lense
Stephen A. Dunn
Summary: The Polyvue Silver Chord and Unisoft Methafilcon A are hydrophilic contact lenses used for vision correction in patients with refractive errors. They are primarily used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway
510K
Number
K980818 ↗
Decision Date
March 30, 1998
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on March 30, 1998, by manufacturer Stephen A. Dunn. It is classified as a Class 2 medical device under product code LPL.
What It Is
The Polyvue Silver Chord and Unisoft Methafilcon A are soft contact lenses made from a hydrophilic material designed to correct refractive errors such as myopia, hyperopia, astigmatism, and presbyopia. These lenses are available in spherical, aspherical, toric, and multifocal designs to accommodate various visual needs. The hydrophilic nature of the lenses allows for high oxygen permeability, enhancing comfort for extended wear.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology practices for patients requiring vision correction. They are suitable for a wide range of patients, including those with astigmatism and presbyopia, who need specialized lens designs. The lenses can be used in both routine eye care settings and specialized contact lens clinics, providing solutions for patients seeking alternatives to glasses.
Indications for Use
The FDA indications suggest these lenses are intended for patients with refractive errors such as nearsightedness, farsightedness, astigmatism, and age-related presbyopia. They offer a non-surgical option for vision correction.
Practical Considerations
These lenses come in various designs to fit different refractive needs, and practitioners should ensure proper fitting and patient education on lens care. Compatibility with different cleaning solutions and wear schedules should be considered to optimize patient comfort and lens longevity.
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 Polyvue Silver Chord and Unisoft Methafilcon A used for?
These are hydrophilic contact lenses used to correct refractive errors like myopia, hyperopia, astigmatism, and presbyopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practices for vision correction.
What are the FDA-cleared indications?
These lenses are indicated for correcting refractive errors such as nearsightedness, farsightedness, astigmatism, and presbyopia.
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.