📋 FDA Reference
Saview-Aqua 58 Uv Etafilcon a Visibility Tinted Soft Hydrophilic Contact Lens Saview-Aqua 58 Uv Toric Etafilcon a
St. Shine Optical
Summary: The saview-aqua 58 UV etafilcon a contact lens is a soft hydrophilic lens designed to provide UV protection. It is used by eye care professionals to help protect patients' eyes from harmful UV radiation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K132146 ↗
Decision Date ?
August 30, 2013
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The saview-aqua 58 UV contact lens by St. Shine Optical was cleared through the FDA 510k pathway on August 30, 2013. It is a Class 2 medical device.
What It Is
The saview-aqua 58 UV etafilcon a contact lens is a soft, hydrophilic lens with UV-blocking properties. Made from etafilcon a, it is designed to fit comfortably on the eye while providing protection against harmful ultraviolet radiation. The lens is visibility tinted to aid in handling and is available in toric designs for patients with astigmatism.
FDA-Cleared Indications
- Correction of refractive errors with a soft hydrophilic contact lens.
- Daily wear use when prescribed and fitted by an eye-care professional.
- UV protection as an additional feature of the contact lens.
- Toric lens correction for patients with astigmatism when the appropriate design is prescribed.
Clinical Applications
- Daily-wear vision correction for patients with refractive errors.
- Correction of astigmatism with the toric version of the lens.
- Use of a visibility-tinted lens to make handling and placement easier.
- Providing UV protection during prescribed contact-lens wear.
Practical Considerations
- The lens must be fitted and prescribed by an eye-care professional; prescription parameters and toric orientation must match the patient's needs.
- Patients should follow the labeled wearing, cleaning, replacement and storage instructions. Poor hygiene or overwear can increase the risk of eye infection and corneal injury.
- The lens is intended for daily wear and should not be worn overnight unless the specific product labeling expressly permits it.
- UV-blocking contact lenses do not replace UV-blocking sunglasses because they do not cover the surrounding skin or the entire eye.
- Contraindications may include active eye infection or inflammation, significant ocular surface disease, inability to follow lens-care instructions, or intolerance to contact-lens wear.
Related Literature
The linked study investigated the UV radiation protection factors of hydrogel and silicone hydrogel contact lenses. It highlighted that UV-blocking lenses can protect the anterior ocular tissues, particularly in the limbal region, from UV-induced damage. The study emphasized the importance of lens thickness in determining UV protection efficacy but did not address long-term clinical outcomes.
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-aqua 58 UV contact lens used for?
It is used for vision correction and to protect the eyes from harmful UV radiation.
What specialties typically use this device?
Optometrists and ophthalmologists commonly prescribe these lenses.
What are the FDA-cleared indications?
The lenses are indicated for vision correction and UV protection in patients requiring refractive correction.
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.