đź“Š Evidence-Based Reference
vistakon lenefilcon a soft hydrophilic contact lenses clear and visibility tint with uv blocker for daily wear
Vistakon, Johnson & Johnson Vision Products
Summary: Vistakon Lenefilcon A are soft hydrophilic contact lenses with UV blocker for daily wear. Primarily used for vision correction. Key evidence includes studies on myopia control and lens fitting stability.
FDA Clearance Information
Pathway
510K
Number
K991163 ↗
Decision Date
June 8, 1999
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Vistakon Lenefilcon A lenses were cleared by the FDA via the 510k pathway on June 8, 1999. Manufactured by Vistakon, Johnson & Johnson Vision Products, they are classified as Class 2 medical devices.
What It Is
Vistakon Lenefilcon A are soft, hydrophilic contact lenses designed for daily wear. They incorporate a UV blocker and are intended for vision correction. These lenses are suitable for patients requiring refractive error correction.
Clinical Applications
Commonly used in scenarios requiring daily vision correction, these lenses are suitable for patients with myopia or other refractive errors. They are also used in studies exploring myopia control in pediatric populations.
Evidence Summary
The literature includes 10 studies ranging from 2009 to 2016, encompassing randomized clinical trials and prospective studies. These studies primarily focus on myopia control, lens fitting stability, and visual acuity.
Reported Outcomes
Published studies report minimal reductions in myopia progression with bifocal contact lenses. Studies also highlight the fitting stability of soft toric lenses and the impact of lens power profiles on peripheral refractive error.
Safety Profile
Reported complications include issues related to lens fitting and orientation. Some studies noted the impact of lens wear on functional visual acuity and higher-order aberrations.
Evidence Limitations
The evidence is limited by the short duration of most studies, often less than two years. Further research is needed to explore long-term outcomes and the effects of lens wear on ocular health.
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 Vistakon Lenefilcon A lenses?
These lenses are indicated for daily wear to correct refractive errors such as myopia.
What outcomes have been reported in clinical studies?
Studies report minimal reductions in myopia progression and insights into lens fitting stability.
What complications have been reported?
Safety data indicate complications related to lens fitting and visual acuity changes.
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.