📋 FDA Reference
Weicon R Tefilicon Hydrophilic Contact Lens
Ciba Vision Care
Summary: The Weicon R Tefilicon Hydrophilic Contact Lens is a soft contact lens used primarily for vision correction. It is utilized by optometrists and ophthalmologists to provide patients with a comfortable alternative to glasses.
FDA Clearance Information
Pathway ?
PMA
Number ?
P810005 ↗
Decision Date ?
April 19, 1982
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Weicon R Tefilicon Hydrophilic Contact Lens was cleared via the FDA's premarket approval (PMA) pathway on April 19, 1982. Manufactured by Ciba Vision Care, it is classified as a Class 2 medical device.
What It Is
The Weicon R Tefilicon Hydrophilic Contact Lens is a type of soft contact lens made from a hydrophilic material, tefilicon, which allows it to absorb water and remain moist on the eye. This design provides comfort and ease of use for patients requiring vision correction. The lens is designed to fit the curvature of the eye, offering a more natural feel compared to rigid lenses.
FDA-Cleared Indications
- Correction of refractive errors, including myopia, hyperopia, and astigmatism, when prescribed and fitted by an eye-care professional.
Clinical Applications
- Vision correction as an alternative to eyeglasses.
- Correction of nearsightedness (myopia).
- Correction of farsightedness (hyperopia).
- Correction of astigmatism when the prescribed lens design and parameters are appropriate.
- Outpatient contact-lens fitting and prescription by an optometrist or ophthalmologist.
Practical Considerations
- The lens must be professionally fitted for the patient's corneal shape, prescription, and wearing schedule.
- Patients should follow the prescribed cleaning, disinfection, replacement, and hand-washing instructions to reduce the risk of eye infection.
- Hydrophilic lenses contain water, but they are not automatically appropriate for patients with dry eye disease; comfort and ocular-surface health should be assessed individually.
- Compatibility with contact-lens solutions, eye drops, cosmetics, and other eye-care products should be reviewed.
- This is an ophthalmic device, not an implanted device; MRI precautions are generally not applicable, but the lens should be removed if directed by the imaging facility or eye-care professional.
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 the Weicon R Tefilicon Hydrophilic Contact Lens used for?
It is used for correcting refractive vision errors such as myopia, hyperopia, and astigmatism.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practice.
What are the FDA-cleared indications?
The lenses are indicated for vision correction in patients with refractive errors.
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.