đź“‹ FDA Reference

power plus polymacon soft hydrophilic aspheric contact lens

Unilens Corp., U

Summary: The Power Plus Polymacon Soft Hydrophilic Aspheric Contact Lens is a vision correction device used primarily by optometrists and ophthalmologists to correct refractive errors. It is suitable for patients requiring high plus power correction.

FDA Clearance Information

Pathway 510K
Decision Date April 10, 1996
Product Code LPL
Device Class Class 2
Evidence 419 studies

This device was cleared through the FDA 510k pathway on April 10, 1996. Manufactured by Unilens Corp., it is classified as a Class 2 medical device under product code LPL.

What It Is

The Power Plus Polymacon Soft Hydrophilic Aspheric Contact Lens is designed to correct refractive errors in patients with significant hyperopia. Made from polymacon, a hydrogel material, these lenses are soft and flexible, allowing for comfortable wear. The aspheric design helps reduce spherical aberrations, providing clearer vision.

Clinical Applications

These contact lenses are commonly used in optometry and ophthalmology clinics for patients with high hyperopia. They are particularly beneficial for individuals who require vision correction beyond the capabilities of standard lenses. The lenses are suitable for both daily wear and extended wear, depending on the patient's needs and eye health.

Indications for Use

The FDA indications suggest this device is intended for patients with significant hyperopia who need high plus power correction. It is suitable for those who prefer contact lenses over glasses for vision correction.

Practical Considerations

These lenses come in various sizes and powers to accommodate different levels of hyperopia. Clinicians should ensure proper fitting to maximize comfort and effectiveness. Regular follow-up appointments are recommended to monitor eye health and lens performance.

Related Literature

The linked study explored the use of corneal volume measurements to monitor corneal swelling in patients wearing high plus power contact lenses. It found that corneal volume could be a useful metric for assessing lens-induced swelling. However, as a pilot study, it had a limited sample size and further research is needed to validate these findings.

Linked Studies (20)

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Clinical progress note: Haemophilus influenzae type b.

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Pilot study of social media promotion of home-based self-testing for syphilis.

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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.

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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.

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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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Editorial - Philippe Ascher (1936-2022).

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Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

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

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Comparative connectomics of Drosophila descending and ascending neurons.

Nature

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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.

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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 Power Plus Polymacon Soft Hydrophilic Aspheric Contact Lens used for?

It is used to correct refractive errors, specifically high hyperopia, by optometrists and ophthalmologists.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these lenses in clinical settings.

What are the FDA-cleared indications?

The device is indicated for patients with significant hyperopia requiring high plus power 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.

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