📋 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 ?
510(k)
Number ?
K133079 ↗
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.
FDA-Cleared Indications
- Daily-wear correction of myopia (nearsightedness).
- Daily-wear correction of hyperopia (farsightedness).
- Daily-wear correction of astigmatism with the toric lens design.
Clinical Applications
- Vision correction for patients with myopia.
- Vision correction for patients with hyperopia.
- Vision correction for patients with astigmatism using the toric lens design.
- Outpatient contact-lens fitting as an alternative to eyeglasses.
Practical Considerations
- The lenses require professional fitting to select the appropriate diameter, base curve, power, and, for toric lenses, astigmatism correction and orientation.
- They are intended for daily wear and should be removed, cleaned, and stored according to the prescribing clinician's and manufacturer's instructions; they should not be worn overnight unless specifically labeled and prescribed for that use.
- Use only compatible contact-lens care products and follow recommended replacement and hygiene schedules.
- Patients with active eye infection, significant ocular inflammation, or other contraindications to contact-lens wear should not use these lenses unless cleared by an eye-care professional.
- Contact lenses are nonmagnetic, but MRI safety also depends on other items the patient may be wearing; lenses should be managed according to the MRI facility's instructions.
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 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.