đź“Š Evidence-Based Reference
Acuvue Etafilcon a Soft Hydrophilic Contact Lenses Clear and Visibility Tint with Uv Blocker for Daily Wear
Vistakon, Johnson & Johnson Vision Products
Summary: Acuvue Etafilcon A are soft hydrophilic contact lenses with UV blocker for daily wear, manufactured by Vistakon. Key evidence highlights their safety and efficacy in various populations.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K991134 ↗
Decision Date ?
May 6, 1999
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Acuvue Etafilcon A lenses were cleared by the FDA through the 510(k) pathway on May 6, 1999. They are manufactured by Vistakon, a division of Johnson & Johnson Vision Products, and are classified as Class 2 medical devices.
What It Is
Acuvue Etafilcon A are soft, hydrophilic contact lenses designed for daily wear. They incorporate a UV blocker and are intended to correct refractive errors by providing a clear optical surface over the cornea.
FDA-Cleared Indications
- Daily-wear vision correction for myopia.
- Daily-wear vision correction for hyperopia.
- Use as soft, hydrophilic contact lenses with a UV-blocking feature and clear or visibility tint.
Clinical Applications
- Correction of nearsightedness with daily-wear contact lenses.
- Correction of farsightedness with daily-wear contact lenses.
- Temporary removal, cleaning, and disinfection according to the prescribed lens-care system.
- Use of a visibility-tinted lens to assist handling without changing the intended optical correction.
Evidence Summary
The literature includes 11 studies, ranging from randomized controlled trials to observational studies, conducted between 2007 and 2022. These studies explore various aspects of lens performance, including comfort, safety, and efficacy.
Reported Outcomes
Published studies report that Acuvue Etafilcon A lenses provide satisfactory vision correction and comfort for most users. They are effective in maintaining ocular health and are associated with high user satisfaction, particularly in pediatric populations.
Safety Profile
Reported complications include minor discomfort and occasional dryness, which are common with contact lens use. No significant adverse events 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 the impact of environmental factors on lens performance.
Practical Considerations
- These lenses are intended for daily wear and should not be worn overnight unless specifically labeled and prescribed for that use.
- The correct base curve, diameter, power, and fit must be selected by an eye-care professional; available parameters vary by product version.
- Users must follow the recommended cleaning, disinfection, replacement, and hand-washing instructions to reduce the risk of infection and corneal injury.
- Do not use the lenses with solutions or medications that are incompatible with the lens material, and do not share lenses.
- A UV-blocking lens does not replace sunglasses, protective eyewear, or other measures that shield the surrounding eye from ultraviolet exposure.
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 Acuvue Etafilcon A lenses?
Acuvue Etafilcon A lenses are indicated for the correction of refractive errors such as myopia and hyperopia in patients requiring daily wear contact lenses.
What outcomes have been reported in clinical studies?
Clinical studies have reported high levels of user satisfaction, effective vision correction, and comfort with Acuvue Etafilcon A lenses.
What complications have been reported?
Safety data from evidence indicate minor discomfort and dryness as the most common complications, with no significant adverse events reported.
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.