📋 FDA Reference
Lifestyle 4-vue Polymacon Hydrophilic Multifocal Contact Lens for Daily Wear
Permeable Technologies
Summary: The Lifestyle 4-Vue Polymacon Hydrophilic Multifocal Contact Lens is designed for daily wear to correct vision in patients with presbyopia. It is primarily used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K963001 ↗
Decision Date ?
March 11, 1997
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Lifestyle 4-Vue Polymacon Hydrophilic Multifocal Contact Lens was cleared through the FDA 510(k) pathway on March 11, 1997. Manufactured by Permeable Technologies, it is classified as a Class 2 medical device.
What It Is
This device is a multifocal contact lens made from polymacon, a hydrophilic material that allows for comfort during daily wear. It is designed to provide clear vision at multiple distances for patients with presbyopia, a condition where the eye's lens loses flexibility with age. The lens works by having multiple zones for different focal points, allowing the wearer to see clearly at varying distances without the need for bifocals or reading glasses.
FDA-Cleared Indications
- Daily-wear vision correction for patients with presbyopia.
- Multifocal correction of near and distance vision.
Clinical Applications
- Correction of age-related presbyopia with a multifocal contact lens.
- Daily-wear correction for patients who need vision at near and far distances.
- Non-surgical vision correction as an alternative to bifocal or reading glasses.
Practical Considerations
- The lens requires fitting by an optometrist or ophthalmologist, including assessment of corneal shape, prescription and lens movement.
- Patients should follow prescribed cleaning, disinfecting, storage and replacement instructions to reduce the risk of infection and corneal injury.
- The lens is intended for daily wear and should not be worn overnight unless specifically directed by an eye-care professional.
- Contraindications may include active eye infection or inflammation, significant dry eye, corneal disease, or inability to follow lens-care instructions.
- This is a non-implantable ophthalmic lens and does not require MRI precautions; it should be removed before MRI or other eye examinations when instructed.
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 Lifestyle 4-Vue Polymacon Hydrophilic Multifocal Contact Lens used for?
It is used to correct vision for patients with presbyopia, allowing them to see clearly at multiple distances.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practice.
What are the FDA-cleared indications?
The lens is indicated for daily wear to correct presbyopia, providing clear vision at multiple distances.
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.