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Aurora Ocufilcon D Soft Hydrophilic Daily Wear Contact Lens Tinted Color
Vizionfocus
Summary: The Aurora Ocufilcon D is a soft hydrophilic daily wear contact lens designed for vision correction. It is primarily used by optometrists and ophthalmologists for patients needing vision correction with a comfortable, daily wear option.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K243953 ↗
Decision Date ?
April 10, 2025
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Aurora Ocufilcon D contact lens by Vizionfocus was cleared through the FDA 510k pathway on April 10, 2025. It is classified as a Class 2 medical device under product code LPL.
What It Is
The Aurora Ocufilcon D is a soft contact lens made from a hydrophilic material, designed for daily wear. It is tinted for easier handling and identification. These lenses work by sitting on the cornea and correcting refractive errors such as myopia or hyperopia, providing clear vision throughout the day. The hydrophilic nature ensures comfort by allowing oxygen permeability and moisture retention.
FDA-Cleared Indications
- Daily-wear vision correction with a soft hydrophilic contact lens.
- Correction of refractive errors, including myopia and hyperopia, as specified by the prescription and labeling.
- Use as a tinted lens to assist with handling and lens identification.
Clinical Applications
- Correction of nearsightedness in patients fitted by an optometrist or ophthalmologist.
- Correction of farsightedness in patients fitted by an optometrist or ophthalmologist.
- Daily daytime wear as a soft contact-lens option for refractive-error correction.
- Single-day use followed by disposal when the product labeling specifies daily disposable use.
Practical Considerations
- The lens must be properly fitted and prescribed by an eye-care professional; available powers, base curves, diameters and other parameters depend on the product labeling.
- Wash and dry hands before handling. Follow the labeling for insertion, removal and disposal, and do not reuse a lens labeled for single-day use.
- Do not sleep, swim or shower while wearing the lenses unless specifically directed by an eye-care professional and permitted by the labeling.
- Patients with eye infection, active inflammation, unexplained redness, significant ocular surface disease or inability to follow lens-care instructions may not be appropriate candidates.
- This is an ophthalmic contact lens, not an implant or intravascular device; MRI compatibility is generally not a relevant device consideration, but the lens should be removed if directed by the imaging facility or clinician.
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 Aurora Ocufilcon D used for?
Aurora Ocufilcon D is used for correcting refractive errors such as myopia and hyperopia in patients who prefer daily disposable contact lenses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practice for vision correction.
What are the FDA-cleared indications?
The lenses are indicated for daily wear to correct refractive errors like nearsightedness or farsightedness, providing a convenient and hygienic option.
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.