đź“‹ FDA Reference

proclear ultravue multifocal and proclear ultravue 2000t multifocal toric omaflicon a soft hydrophilic contact lens

Opti-Centre Laboratories

Summary: The Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric are soft hydrophilic contact lenses designed for vision correction in patients with presbyopia and astigmatism. They are primarily used by optometrists and ophthalmologists.

FDA Clearance Information

Pathway 510K
Decision Date January 12, 2005
Product Code LPL
Device Class Class 2
Evidence 419 studies

The Proclear Ultravue Multifocal lenses were cleared through the FDA's 510(k) pathway on January 12, 2005. Manufactured by Opti-Centre Laboratories, these lenses are classified as Class 2 medical devices.

What It Is

The Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric lenses are soft, hydrophilic contact lenses made from omafilcon A. They are designed to correct vision in patients with presbyopia, a condition that affects near vision as people age, and astigmatism, which causes blurred vision. The lenses use a multifocal design to provide clear vision at multiple distances, enhancing visual acuity and comfort for the wearer.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology practices for patients who require correction for both presbyopia and astigmatism. They are suitable for a wide range of patients, including those who prefer contact lenses over glasses for aesthetic or lifestyle reasons. The lenses are typically fitted in outpatient settings, such as eye clinics or private practices, and are particularly beneficial for patients who need clear vision for both near and far tasks.

Indications for Use

The FDA has cleared these lenses for use in correcting vision in patients with presbyopia and astigmatism. They help patients who have difficulty focusing on near objects due to aging and those with irregularly shaped corneas that cause blurred vision.

Practical Considerations

These lenses are available in various sizes to fit different eye shapes and prescriptions. They are compatible with standard contact lens solutions and require proper fitting by a qualified eye care professional. Regular follow-up appointments are recommended to ensure optimal vision correction and eye health.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

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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

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PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

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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

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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

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PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

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PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

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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

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PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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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

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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

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PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

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PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

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Frequently Asked Questions

What is Proclear Ultravue Multifocal used for?

It is used for correcting vision in patients with presbyopia and astigmatism.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these lenses in their practices.

What are the FDA-cleared indications?

The lenses are indicated for correcting presbyopia and astigmatism to improve vision clarity.

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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