đź“‹ FDA Reference
biocurve soft ew methafilcon a hydrophilic contact lenses
Wavetouch Technologies
Summary: Biocurve Soft EW Methafilcon A lenses are hydrophilic contact lenses with a visibility tint, used for vision correction. They are primarily used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway
PMA
Number
P860040 ↗
Decision Date
November 4, 1997
Product Code
LPM
Device Class
Class 3
Evidence
419 studies
The Biocurve Soft EW Methafilcon A lenses were cleared through the FDA's premarket approval (PMA) process on November 4, 1997. Manufactured by Wavetouch Technologies, this Class 3 device is approved for adding a visibility tint.
What It Is
The Biocurve Soft EW Methafilcon A lenses are extended wear hydrophilic contact lenses designed for vision correction. These lenses incorporate a visibility tint, making them easier to handle and apply. The methafilcon A material is known for its water content, providing comfort and breathability for extended wear.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology for patients requiring vision correction, such as those with myopia or hyperopia. They are suitable for daily or extended wear, depending on the patient's needs and eye health. The lenses are typically fitted in clinical settings, with follow-up visits to ensure proper fit and eye health.
Indications for Use
The FDA-cleared indications allow for a visibility tint to be added to the lenses, aiding in handling and application. These lenses are intended for patients needing vision correction, without altering the previously approved uses.
Practical Considerations
These lenses are available in various sizes and prescriptions to accommodate different patient needs. They are compatible with standard contact lens solutions and require proper hygiene and handling techniques to maintain eye health.
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 Biocurve Soft EW Methafilcon A used for?
These lenses are used for correcting vision in patients with refractive errors like myopia and hyperopia.
What specialties typically use this device?
Optometrists and ophthalmologists commonly use these lenses in their practice.
What are the FDA-cleared indications?
The lenses are cleared for vision correction with an added visibility tint for easier handling.
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.