📋 FDA Reference
Esstech Multi Toric Aspheric Multifocal Hioxifilcon B Soft Hydrophilic Contact Lens for Daily Wear Clear and Tint
Les Laboratoires Blanchard
Summary: The Esstech Multi Toric Aspheric Multifocal Hioxifilcon B lens is a soft hydrophilic contact lens designed for daily wear. It is used to correct refractive errors such as astigmatism and presbyopia. Ophthalmologists and optometrists typically prescribe it for patients needing multifocal vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003161 ↗
Decision Date ?
December 15, 2000
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on December 15, 2000. It is manufactured by Les Laboratoires Blanchard and classified as a Class 2 medical device under product code LPL.
What It Is
The Esstech Multi Toric Aspheric Multifocal Hioxifilcon B lens is a soft contact lens designed to correct both astigmatism and presbyopia. Made from Hioxifilcon B, a hydrophilic material, it provides comfort and clear vision for daily wear. The lens features a toric design to address astigmatism and a multifocal design to aid in near and distance vision, making it suitable for patients with complex refractive needs.
FDA-Cleared Indications
- Daily-wear vision correction with a soft hydrophilic contact lens.
- Correction of astigmatism with a toric lens design.
- Multifocal correction for patients who need vision correction at near and distance.
Clinical Applications
- Daily contact-lens correction for patients with astigmatism.
- Multifocal contact-lens correction for presbyopia-related near-vision needs.
- Correction of combined astigmatism and presbyopia in appropriately fitted patients.
- Use of clear or tinted lenses according to the prescribed lens option and patient preference.
Practical Considerations
- The lens must be fitted and prescribed by a qualified eye-care professional; fit, prescription, corneal shape and visual requirements should be evaluated before use.
- Patients should follow the prescribed wearing schedule and cleaning, disinfection and replacement instructions. Daily-wear lenses should not be worn overnight unless specifically labeled and prescribed for that use.
- Proper hand hygiene and lens care are important to reduce the risk of corneal infection and other complications.
- Patients with active eye infection, significant ocular inflammation or other contraindications to contact-lens wear may not be appropriate candidates.
- As a contact lens, it is not an implanted device and has no special MRI-related restriction; it should be managed according to the eye-care professional'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 the Esstech Multi Toric Aspheric Multifocal Lens used for?
It is used to correct vision for patients with astigmatism and presbyopia, providing clear vision at multiple distances.
What specialties typically use this device?
Ophthalmologists and optometrists typically use this device in their practice.
What are the FDA-cleared indications?
The lens is indicated for the correction of astigmatism and presbyopia in patients who prefer contact lenses for daily wear.
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.