📋 FDA Reference
S-42 Uv T-42 Uv Toric and M-42 Uv Multifocal Hefilcon a Soft Hydrophilic Contact Lens for Daily Wear
Optical Connection
Summary: The s-42 uv t-42 uv toric and m-42 uv multifocal are soft hydrophilic contact lenses designed for daily wear. They are used to correct refractive errors such as astigmatism and presbyopia. These lenses are typically used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K040900 ↗
Decision Date ?
June 15, 2004
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on June 15, 2004. Manufactured by Optical Connection, it is classified as a Class 2 medical device under product code LPL.
What It Is
The s-42 uv t-42 uv toric and m-42 uv multifocal are soft contact lenses made from hefilcon A, a hydrophilic material that allows for comfortable daily wear. The toric version is designed to correct astigmatism, while the multifocal version addresses presbyopia by providing multiple focal points. These lenses incorporate UV protection, adding an extra layer of eye safety.
FDA-Cleared Indications
- Daily-wear correction of refractive errors with the s-42 uv soft hydrophilic contact lens.
- Daily-wear correction of astigmatism with the t-42 uv toric soft hydrophilic contact lens.
- Daily-wear correction of presbyopia with the m-42 uv multifocal soft hydrophilic contact lens.
Clinical Applications
- Correction of refractive error in patients who require contact-lens vision correction.
- Correction of astigmatism with the toric lens design.
- Correction of presbyopia with the multifocal lens design.
- Daily daytime wear with removal according to the prescribed lens-care schedule.
Practical Considerations
- The lenses must be fitted and prescribed by an eye-care professional, with selection based on refraction, corneal shape, lens parameters, and visual requirements.
- Daily-wear lenses should generally be removed before sleeping unless the specific labeling and clinician instructions state otherwise.
- Patients should follow the prescribed cleaning, disinfection, replacement, and handling instructions; improper care increases the risk of eye infection and corneal injury.
- Patients with active eye infection, significant ocular inflammation, or conditions that interfere with contact-lens wear may not be appropriate candidates.
- The lenses are used on the eye and do not create a meaningful MRI-safety issue; patients should still follow the imaging center's instructions and remove lenses if requested.
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 s-42 uv t-42 uv toric and m-42 uv multifocal used for?
These lenses are used to correct astigmatism and presbyopia, providing clear vision for patients with these refractive errors.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these contact lenses for vision correction.
What are the FDA-cleared indications?
These lenses are cleared for correcting refractive errors such as astigmatism and presbyopia in patients who prefer contact lenses.
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.