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eni-eye sh sphere efrofilcon a soft hydrophilic contact lens for daily wear
Soflex
Summary: The eni-eye sh sphere efrofilcon a is a soft hydrophilic contact lens designed for daily wear. It is used primarily for vision correction in patients requiring spherical lenses. Optometrists and ophthalmologists typically prescribe this device.
FDA Clearance Information
Pathway
510K
Number
K122213 ↗
Decision Date
December 12, 2012
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The eni-eye sh sphere efrofilcon a contact lens was cleared through the FDA 510(k) pathway on December 12, 2012. Manufactured by Soflex, it is classified as a Class 2 medical device under product code LPL.
What It Is
The eni-eye sh sphere efrofilcon a is a soft, hydrophilic contact lens made from efrofilcon A, designed for daily wear. It is used to correct refractive errors in patients who require spherical lenses. The lens material allows for high oxygen permeability, enhancing comfort and eye health during wear. Its design ensures a stable fit and clear vision throughout the day.
Clinical Applications
This contact lens is commonly used in optometry and ophthalmology clinics for patients with myopia or hyperopia. It is suitable for a wide range of patients, including those who prefer not to wear glasses or require contact lenses for sports or aesthetic reasons. The lens is typically prescribed for daily wear, making it ideal for patients seeking convenience and ease of use.
Indications for Use
The FDA indications suggest that this contact lens is intended for the correction of refractive errors such as nearsightedness or farsightedness. It is suitable for patients who need spherical correction and prefer a soft lens for daily use.
Practical Considerations
The lens is available in various diopters to accommodate different levels of refractive error. It is important to ensure proper lens fitting and hygiene to prevent complications. Patients should be instructed on proper insertion, removal, and cleaning techniques to maintain lens integrity and eye 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 is eni-eye sh sphere efrofilcon a used for?
It is used for correcting refractive errors such as myopia and hyperopia in patients who require spherical lenses.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe and fit these contact lenses.
What are the FDA-cleared indications?
The lens is indicated for the correction of refractive errors like nearsightedness or farsightedness in patients requiring spherical correction.
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.