đź“‹ FDA Reference

barbie polymacon daily wear soft hydrophilic contact lens

Shenzhen Dashicheng Optical Technology

Summary: The Barbie Polymacon Daily Wear Soft Hydrophilic Contact Lens is a vision correction device used by optometrists and ophthalmologists for patients requiring daily wear lenses. It is designed for comfort and ease of use.

FDA Clearance Information

Pathway 510K
Decision Date September 8, 2022
Product Code LPL
Device Class Class 2
Evidence 419 studies

This device was cleared through the FDA 510(k) pathway on September 8, 2022. Manufactured by Shenzhen Dashicheng Optical Technology, it is classified as a Class 2 medical device under product code LPL.

What It Is

The Barbie Polymacon Daily Wear Soft Hydrophilic Contact Lens is a type of contact lens made from polymacon, a hydrogel material that retains moisture and provides comfort for daily wear. These lenses are designed to correct refractive errors such as myopia and hyperopia, offering an alternative to glasses. The hydrophilic nature of the lens helps maintain hydration, making it suitable for extended wear throughout the day.

Clinical Applications

These contact lenses are commonly used in optometry and ophthalmology practices for patients needing vision correction. They are ideal for individuals who prefer contact lenses over glasses for aesthetic or practical reasons. The lenses are typically prescribed for daily wear, meaning they should be removed and cleaned each night. They are suitable for a wide range of patients, including those with mild to moderate refractive errors.

Indications for Use

The FDA indications suggest that this lens is intended for daily wear to correct refractive errors like nearsightedness and farsightedness. It is suitable for patients who need vision correction and prefer contact lenses over eyeglasses.

Practical Considerations

These lenses are available in various sizes to fit different corneal curvatures and diameters. They are designed for daily wear, meaning they should be removed before sleeping. Compatibility with standard contact lens solutions for cleaning and storage is expected, but specific recommendations should be followed based on the manufacturer's guidelines.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 Barbie Polymacon Daily Wear Soft Hydrophilic Contact Lens used for?

It is used for correcting refractive errors such as myopia and hyperopia in patients who prefer contact lenses over glasses.

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 lens is indicated for daily wear to correct refractive errors like nearsightedness and farsightedness in patients who prefer contact lenses.

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.

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