đź“Š Evidence-Based Reference
vistakon lenefilcon a soft hydrophilic contact lens clear and visibility tinted with uv blocker
Johnson & Johnson Vision Care
Summary: The Vistakon Lenefilcon A is a soft hydrophilic contact lens with UV blocker, primarily used for correcting refractive ametropia. Key evidence includes studies on myopia control and lens fitting stability.
FDA Clearance Information
Pathway
PMA
Number
P990085 ↗
Decision Date
February 16, 2001
Product Code
LPM
Device Class
Class 3
Evidence
419 studies
The Vistakon Lenefilcon A contact lens was cleared by the FDA via the PMA pathway on February 16, 2001. It is manufactured by Johnson & Johnson Vision Care and classified as a Class 3 device.
What It Is
The Vistakon Lenefilcon A is a soft hydrophilic contact lens designed for daily and extended wear. It is used to correct refractive ametropia, including myopia and hyperopia, and features a UV blocker for added protection.
Clinical Applications
Commonly used in patients with non-diseased eyes for correcting myopia and hyperopia. It is also suitable for individuals with mild astigmatism and can be used in aphakic patients for daily wear.
Evidence Summary
The literature includes 10 studies, primarily randomized clinical trials, published between 2009 and 2016. These studies explore aspects such as myopia control, lens fitting stability, and visual acuity.
Reported Outcomes
Published studies report minimal reductions in myopia progression with bifocal lenses, with some effects noted in children with nearpoint esophoria. Other studies focus on lens orientation and visual acuity differences with tinted lenses.
Safety Profile
Reported complications include minimal adverse effects related to lens fitting and visual acuity. No significant safety concerns were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and short duration of some studies. Further research is needed to explore long-term outcomes and safety in diverse populations.
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?
The lens is indicated for correcting refractive ametropia in non-aphakic persons with non-diseased eyes and for daily wear in aphakic persons.
What outcomes have been reported in clinical studies?
Studies report minimal reductions in myopia progression and differences in visual acuity with tinted lenses.
What complications have been reported?
Reported complications include minimal adverse effects related to lens fitting and visual acuity.
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.