📋 FDA Reference
Saview 58 Uv Toric Multifocal Etafilcon a Soft Hydrophilic Contact Lens for Daily Wear
St. Shine Optical
Summary: The saview 58 UV Toric Multifocal Contact Lens is a soft hydrophilic contact lens for daily wear, designed for patients needing vision correction for astigmatism and presbyopia. It is typically used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K092852 ↗
Decision Date ?
March 11, 2010
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The saview 58 UV Toric Multifocal Contact Lens was cleared through the FDA 510(k) pathway on March 11, 2010. Manufactured by St. Shine Optical, this device is classified as a Class 2 medical device under product code LPL.
What It Is
The saview 58 UV Toric Multifocal Contact Lens is a soft, hydrophilic contact lens made from etafilcon A, designed for daily wear. It incorporates UV-blocking technology and is intended to correct both astigmatism and presbyopia, providing multifocal vision correction. The lens is designed to maintain hydration and comfort throughout the day, making it suitable for extended periods of wear.
FDA-Cleared Indications
- Daily-wear vision correction for astigmatism.
- Multifocal vision correction for presbyopia.
- Use in patients requiring correction of both astigmatism and presbyopia.
Clinical Applications
- Daily-wear contact lens correction for adults with astigmatism.
- Multifocal contact lens correction for patients with presbyopia.
- Correction of combined astigmatism and presbyopia when prescribed and fitted by an eye-care professional.
- Use as an alternative to glasses for patients who require toric and multifocal vision correction.
Practical Considerations
- The lens requires professional fitting based on the patient's prescription, corneal shape, astigmatism, presbyopia and visual needs.
- It is intended for daily wear and should be removed, cleaned and disinfected according to the prescribing clinician's instructions; it should not be worn overnight unless specifically labeled and prescribed for that use.
- Patients should follow the recommended replacement schedule and should not use tap water or saliva for cleaning or storing the lens.
- Do not use the lens with an eye infection, significant eye inflammation, or other contraindications identified by the eye-care professional.
- As a nonimplanted contact lens, MRI compatibility is generally not a concern; the lens should be removed before MRI unless the imaging facility provides different 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 saview 58 UV Toric Multifocal Contact Lens used for?
It is used for correcting astigmatism and presbyopia in patients who prefer contact lenses over glasses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practice.
What are the FDA-cleared indications?
The lens is indicated for correcting refractive errors such as astigmatism and presbyopia in adults, 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.