đź“‹ FDA Reference

hydrogenics 2 0 uv asphere ocufilcon f soft hydrophilic contact lens for extended wear

The Cooper Companies

Summary: The Hydrogenics 2.0 UV Asphere is a soft contact lens designed for extended wear, used to correct myopia and hyperopia with some astigmatism. It is intended for patients with healthy eyes who require vision correction.

FDA Clearance Information

Pathway PMA
Decision Date September 24, 2004
Product Code LPM
Device Class Class 3
Evidence 419 studies

The Hydrogenics 2.0 UV Asphere contact lens by The Cooper Companies was cleared by the FDA under PMA P890023 on September 24, 2004. It is a Class 3 medical device.

What It Is

The Hydrogenics 2.0 UV Asphere is a soft, hydrophilic contact lens made from ocufilcon F material. It incorporates an aspheric design to improve visual acuity by reducing spherical aberrations. The lens is also UV-blocking, providing additional protection against ultraviolet light exposure. It is designed for extended wear, offering convenience for patients who prefer not to remove their lenses daily.

Clinical Applications

This contact lens is commonly used in optometry and ophthalmology settings for patients with myopia or hyperopia, with or without mild astigmatism. It is suitable for individuals seeking a convenient vision correction solution that can be worn for extended periods. The lens is particularly beneficial in busy clinical practices where patients may prefer fewer follow-up visits for lens care.

Indications for Use

The Hydrogenics 2.0 UV Asphere contact lens is indicated for patients who are nearsighted or farsighted and may have some degree of astigmatism. It is suitable for individuals with healthy eyes who need vision correction and prefer a lens that can be worn continuously for extended periods.

Practical Considerations

The lens is available in a range of powers to accommodate different levels of refractive error. It is important to ensure proper fitting to maximize comfort and visual performance. Regular follow-up appointments are recommended to monitor eye health and lens condition during extended wear.

Linked Studies (20)

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Clinical progress note: Haemophilus influenzae type b.

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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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Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

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

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

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

The Journal of clinical investigation

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

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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

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pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

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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 the Hydrogenics 2.0 UV Asphere Contact Lens used for?

It is used to correct myopia and hyperopia, with or without mild astigmatism, in patients with healthy eyes.

What specialties typically use this device?

Optometrists and ophthalmologists commonly use this contact lens in their practice.

What are the FDA-cleared indications?

The lens is indicated for correcting visual acuity in non-diseased eyes that are myopic or hyperopic and may have refractive astigmatism.

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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