đź“‹ FDA Reference
hema for vistakon etafilcon a soft hydrophilic contact lenses
Vistakon, Johnson & Johnson Vision Products
Summary: The hema for Vistakon Etafilcon A lenses are soft hydrophilic contact lenses used primarily for vision correction. They are utilized by optometrists and ophthalmologists for patients requiring corrective lenses.
FDA Clearance Information
Pathway
PMA
Number
N18033 ↗
Decision Date
May 20, 2009
Product Code
LPM
Device Class
Class 3
Evidence
419 studies
The hema for Vistakon Etafilcon A lenses received FDA clearance under PMA N18033 on May 20, 2009. Manufactured by Vistakon, a division of Johnson & Johnson Vision Products, this device is classified as Class 3.
What It Is
This device is a type of soft hydrophilic contact lens made from etafilcon A, a material known for its comfort and oxygen permeability. The lenses are designed to correct refractive errors such as myopia and hyperopia. They work by altering the way light enters the eye, providing clear vision without the need for glasses.
Clinical Applications
These lenses are commonly used in optometry and ophthalmology clinics for patients needing vision correction. They are suitable for daily wear and are often prescribed for patients who prefer contact lenses over glasses. The lenses are particularly beneficial for active individuals or those involved in sports.
Indications for Use
The FDA indication involves a change to an alternate supplier for the critical material, HEMA, used in the production of these lenses. This ensures continued quality and availability of the lenses for patients needing vision correction.
Practical Considerations
These lenses are available in various prescriptions to accommodate different levels of refractive error. They are compatible with standard lens care solutions. Proper fitting and handling techniques are essential to ensure comfort and effectiveness.
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 hema for Vistakon Etafilcon A lenses used for?
These lenses are used for correcting refractive vision errors such as myopia and hyperopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in clinical practice.
What are the FDA-cleared indications?
The indication involves a change to an alternate supplier for the HEMA material used in lens production, ensuring quality and availability.
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.