đź“‹ FDA Reference
polyvue 43 ocufilcon a spherical toric and aspherical multifocal hydrophilic contact lenses for daily wear
Optech
Summary: Polyvue 43 Ocufilcon A lenses are hydrophilic contact lenses designed for daily wear. They are used to correct refractive errors such as astigmatism and presbyopia. Optometrists and ophthalmologists typically prescribe these lenses.
FDA Clearance Information
Pathway
510K
Number
K982110 ↗
Decision Date
November 6, 1998
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Polyvue 43 Ocufilcon A lenses were cleared through the FDA's 510k pathway on November 6, 1998. Manufactured by Optech, these lenses are classified as Class 2 medical devices under product code LPL.
What It Is
The Polyvue 43 Ocufilcon A lenses are soft, hydrophilic contact lenses made from ocufilcon A material. They are available in spherical, toric, and aspherical multifocal designs to address various refractive errors. These lenses work by altering the path of light entering the eye, thereby correcting vision for conditions like astigmatism and presbyopia. Their hydrophilic nature ensures comfort for daily wear.
Clinical Applications
These lenses are commonly used in optometry and ophthalmology settings for patients requiring vision correction for astigmatism or presbyopia. They are suitable for adults and older adults who prefer contact lenses over glasses. The lenses are typically prescribed during routine eye exams and are part of a broader vision correction plan.
Indications for Use
The FDA-cleared indications for these lenses include correction of refractive errors such as astigmatism and presbyopia. They are intended for daily wear by individuals who require vision correction but prefer contact lenses over spectacles.
Practical Considerations
Polyvue 43 lenses come in various sizes and prescriptions to fit different eye shapes and refractive needs. They are designed for daily wear, meaning they should be removed before sleeping. Proper lens care and hygiene are essential to maintain eye health and lens performance.
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 Polyvue 43 Ocufilcon A used for?
These lenses are used to correct refractive errors like astigmatism and presbyopia in patients who prefer contact lenses.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these lenses during routine eye care.
What are the FDA-cleared indications?
The lenses are indicated for correcting astigmatism and presbyopia in individuals requiring vision correction.
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.