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Polyvue Polymacon Soft Hydrophilic Contact Lens Polyvue Color Polymacon Soft Hydrophilic Contact Lens
Interojo
Summary: The Polyvue Polymacon Soft Hydrophilic Contact Lens is a contact lens used for vision correction. It is typically used by optometrists and ophthalmologists for patients needing vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K221517 ↗
Decision Date ?
October 4, 2022
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Polyvue Polymacon Soft Hydrophilic Contact Lens by Interojo was cleared via the FDA 510k pathway on October 4, 2022. It is classified as a Class 2 medical device.
What It Is
The Polyvue Polymacon Soft Hydrophilic Contact Lens is a soft contact lens made from polymacon, a hydrogel material that retains moisture and provides comfort for the wearer. It is designed to correct refractive errors such as myopia or hyperopia by altering the path of light entering the eye, thus improving vision clarity. The lens is available in various colors, offering both cosmetic and corrective benefits.
FDA-Cleared Indications
- Correction of myopia (nearsightedness).
- Correction of hyperopia (farsightedness).
- Vision correction with a soft hydrophilic contact lens in patients prescribed contact-lens correction.
Clinical Applications
- Daily vision correction for nearsightedness.
- Daily vision correction for farsightedness.
- Fitting and prescribing by an eye-care professional for patients who need contact-lens correction.
- Use of colored lens options when included in the prescribed lens design and labeling.
Practical Considerations
- The lens must be professionally fitted to the patient’s eye and prescription; available parameters and sizes should be confirmed in the current product labeling.
- Follow the manufacturer’s instructions for cleaning, disinfection, storage, replacement and wearing time. Do not use tap water or saliva to clean or store the lens.
- Poor hygiene, overnight wear when not prescribed, or wearing a damaged lens can increase the risk of corneal infection and other eye complications.
- Patients with eye inflammation, active infection, significant dry eye or other contraindications to contact-lens wear may not be appropriate candidates and require evaluation by an eye-care professional.
- MRI safety is generally not a major issue for soft, nonmetallic contact lenses, but the patient should remove the lenses before MRI when possible and follow the imaging facility’s instructions.
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 the Polyvue Polymacon Soft Hydrophilic Contact Lens used for?
It is used for correcting refractive errors like myopia and hyperopia, providing clear vision for patients who prefer contact lenses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practice for vision correction.
What are the FDA-cleared indications?
The device is indicated for the correction of refractive errors such as nearsightedness and farsightedness in patients who prefer contact lenses.
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.