Savie-Aqua 55uv Methafilcon a Tinnted Blue Soft Hydrophilic Contact Lens
St. Shine Optical
FDA Clearance Information
The savie-aqua 55uv methafilcon a was cleared by the FDA through the 510(k) pathway on October 26, 2012. It is manufactured by St. Shine Optical and classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Vision correction with a soft hydrophilic contact lens
- Correction of refractive errors such as myopia or hyperopia
- Use of a blue-tinted lens to assist with handling and visibility
Clinical Applications
- Daily vision correction for nearsightedness
- Daily vision correction for farsightedness
- Temporary removal, insertion, and handling of a visible tinted contact lens
- Correction of refractive error when prescribed and fitted by an eye-care professional
Reported off-label uses
- Use as a therapeutic bandage lens for selected corneal surface conditions
- Use as a vehicle for topical ophthalmic medication delivery in clinical research or selected specialist practice
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The lens must be professionally fitted; the appropriate base curve, diameter, power, and wearing schedule depend on the individual eye.
- Methafilcon A is a hydrophilic soft lens material. Follow the prescribed cleaning, disinfection, replacement, and wearing instructions, and do not share lenses.
- Do not wear the lens during sleep, swimming, or showering unless an eye-care professional specifically directs otherwise.
- Avoid use or seek prompt eye-care advice if there is eye redness, pain, discharge, light sensitivity, reduced vision, or suspected infection.
- This is an ophthalmic contact lens, not an implant or intravascular device; MRI compatibility is generally not a relevant safety issue, but the lens should be removed if requested by the imaging facility.
Linked Studies (20)
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →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 →Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →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 →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 →Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →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 →Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →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 →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 →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 →Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →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 →Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →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 →History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →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 are the clinical indications for savie-aqua 55uv methafilcon a?
The device is indicated for vision correction in conditions such as myopia and hyperopia.
What outcomes have been reported in clinical studies?
Studies have reported effects on ocular surface health and the potential for sustained drug delivery.
What complications have been reported?
Safety data indicate potential changes in ocular surface parameters and biofilm formation affecting drug diffusion.