đź“Š Evidence-Based Reference
Bayvue Polymacon Soft Hydrophilic Contact Lens
Unilens Corp., U
Summary: The Bayvue Polymacon Soft Hydrophilic Contact Lens is a soft contact lens designed for vision correction. It is FDA-cleared and supported by studies focusing on material properties and ocular health.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940777 ↗
Decision Date ?
April 12, 1994
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Bayvue Polymacon Soft Hydrophilic Contact Lens was cleared through the FDA 510(k) pathway on April 12, 1994. Manufactured by Unilens Corp., it is classified as a Class 2 medical device.
What It Is
The Bayvue Polymacon Soft Hydrophilic Contact Lens is a vision correction device made from polymacon, a hydrophilic material. It is intended for daily wear to correct refractive errors.
FDA-Cleared Indications
- Daily-wear vision correction for myopia.
- Daily-wear vision correction for hyperopia.
Clinical Applications
- Correction of nearsightedness with a soft contact lens.
- Correction of farsightedness with a soft contact lens.
- Daily-wear visual correction under the fitting and care instructions provided by an eye-care professional.
Evidence Summary
The literature includes 10 studies, ranging from 2004 to 2021, covering various aspects of soft contact lens use, including material properties and ocular health. Study types include RCTs and observational studies.
Reported Outcomes
Published studies report that the Bayvue Polymacon lens maintains tear film stability and offers sustained drug release capabilities. It also shows reduced bacterial adhesion and maintains physical properties like wettability and refractive index.
Safety Profile
Reported complications include potential for bacterial adhesion, as seen with Pseudomonas aeruginosa and Candida albicans. However, the lens material is generally biocompatible and non-toxic.
Evidence Limitations
Evidence gaps include limited long-term safety data and a need for larger-scale studies to confirm efficacy in diverse populations. Further research is needed on the impact of lens material on ocular health over extended periods.
Practical Considerations
- The lens must be fitted by an eye-care professional; diameter, base curve, and corrective power should match the patient's eye and prescription.
- Polymacon is a hydrophilic material that absorbs water, so the lens should be kept hydrated in the recommended contact-lens solution and never stored dry unless the labeling specifically permits it.
- Follow the labeled wearing schedule, cleaning instructions, replacement schedule, and hand-washing requirements to reduce the risk of infection and corneal injury.
- Do not wear the lens with active eye infection, significant redness or pain, unexplained vision changes, or other contraindications identified by an eye-care professional.
- Contact lenses are nonimplantable ophthalmic devices and are not relevant to MRI compatibility; they should generally be removed before MRI 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 are the clinical indications for Bayvue Polymacon Soft Hydrophilic Contact Lens?
Indicated for vision correction in patients with myopia or hyperopia.
What outcomes have been reported in clinical studies?
Studies report stable tear film, sustained drug release, and reduced bacterial adhesion.
What complications have been reported?
Safety data indicate potential bacterial adhesion, but overall biocompatibility is good.
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.