đź“‹ FDA Reference
legacy ocufilcon d performance- tinted soft hydrophilic daily wear contact lenses
Vizionfocus
Summary: The legacy ocufilcon d performance-tinted soft hydrophilic daily wear contact lenses are designed for vision correction and are used by optometrists and ophthalmologists. They are suitable for daily wear by patients requiring vision correction.
FDA Clearance Information
Pathway
510K
Number
K192225 ↗
Decision Date
December 9, 2019
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on December 9, 2019. Manufactured by Vizionfocus, it is classified as a Class 2 medical device under product code LPL.
What It Is
The legacy ocufilcon d contact lenses are soft, hydrophilic lenses designed for daily wear. Made from ocufilcon D material, these lenses are tinted for performance, enhancing visual acuity and comfort. They are intended for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology practices for patients needing vision correction. They are suitable for a wide range of patients, including those with mild to moderate refractive errors. The lenses are typically prescribed for daily wear, providing a convenient option for patients who prefer not to wear glasses.
Indications for Use
The FDA indications suggest these lenses are for patients with vision issues such as nearsightedness or farsightedness. They are suitable for individuals who do not have eye diseases and require corrective lenses for daily activities.
Practical Considerations
These lenses are available in various sizes to fit different corneal shapes and are compatible with standard lens care solutions. Clinicians should ensure proper fitting and educate patients on correct lens handling and hygiene to prevent complications.
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 legacy ocufilcon d performance-tinted soft hydrophilic daily wear contact lenses used for?
These lenses are used for correcting refractive errors such as myopia and hyperopia in patients with non-diseased eyes.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practice for vision correction.
What are the FDA-cleared indications?
These lenses are indicated for the correction of refractive ametropia in individuals with non-diseased eyes, suitable 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.