đź“‹ FDA Reference

io2 spher mangofilcon a soft hydrophilic contact lens for daily wear io2 toric mangofilcon a soft hydrophilic

Alden Optical Labs.

Summary: The io2 spher and toric mangofilcon a contact lenses are soft hydrophilic lenses designed for daily wear. They are used by optometrists and ophthalmologists to correct refractive errors in patients.

FDA Clearance Information

Pathway 510K
Decision Date December 17, 2013
Product Code LPL
Device Class Class 2
Evidence 419 studies

The io2 spher and toric contact lenses by Alden Optical Labs were cleared through the FDA 510(k) pathway on December 17, 2013. They are classified as Class 2 medical devices under product code LPL.

What It Is

The io2 spher and toric contact lenses are soft, hydrophilic lenses made from mangofilcon a material. They are designed for daily wear to correct refractive errors such as myopia, hyperopia, and astigmatism. These lenses offer comfort and ease of use, making them suitable for a wide range of patients seeking vision correction.

Clinical Applications

These contact lenses are commonly used in optometry and ophthalmology clinics for patients requiring vision correction. They are suitable for individuals with myopia, hyperopia, and astigmatism, providing a non-surgical option for vision improvement. The lenses are typically prescribed in outpatient settings and are popular among patients who prefer contact lenses over glasses.

Indications for Use

The io2 spher and toric lenses are indicated for patients with refractive errors such as nearsightedness, farsightedness, and astigmatism. They are designed for daily wear and provide an alternative to eyeglasses for vision correction.

Practical Considerations

These lenses are available in various sizes to fit different corneal shapes and prescriptions. They are compatible with standard contact lens solutions for cleaning and storage. Proper fitting and patient education on lens care are essential for optimal results.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 io2 spher mangofilcon a contact lens used for?

It is used to correct refractive errors such as myopia, hyperopia, and astigmatism.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these contact lenses.

What are the FDA-cleared indications?

The lenses are indicated for daily wear to correct refractive errors like nearsightedness, farsightedness, and astigmatism.

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.

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