đź“‹ FDA Reference

sof-form 55 methafilcon a soft hydrophilic lens

Unilens Corp., U

Summary: The sof-form 55 methafilcon a lens is a soft hydrophilic contact lens used for vision correction. It is primarily used by optometrists and ophthalmologists for patients requiring vision correction.

FDA Clearance Information

Pathway PMA
Decision Date June 29, 1992
Product Code LPM
Device Class Class 3
Evidence 419 studies

The sof-form 55 methafilcon a lens received FDA clearance through the premarket approval (PMA) pathway on June 29, 1992. Manufactured by Unilens Corp., this device is classified as Class 3 under product code LPM.

What It Is

The sof-form 55 methafilcon a lens is a soft contact lens made from methafilcon A, a hydrophilic material that retains moisture and ensures comfort for the wearer. These lenses are designed to correct refractive errors such as myopia or hyperopia by focusing light directly onto the retina. The hydrophilic nature of the lens material allows for high oxygen permeability, which is crucial for maintaining corneal health.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology practices for patients who require vision correction. They are suitable for a wide range of patients, including those with active lifestyles who prefer contact lenses over glasses. The lenses are typically fitted in outpatient settings and can be prescribed for daily wear, depending on the patient's needs and eye health.

Indications for Use

The FDA-cleared indication for the sof-form 55 methafilcon a lens is for vision correction in patients with refractive errors. This includes conditions such as nearsightedness (myopia) and farsightedness (hyperopia), where the lens helps focus light properly onto the retina.

Practical Considerations

These lenses are available in various sizes and prescriptions to accommodate different patient needs. Proper fitting by an eye care professional is essential to ensure comfort and effectiveness. Patients should be instructed on proper lens care and hygiene to prevent infections and maintain lens integrity.

Linked Studies (20)

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Journal of neuroendovascular therapy

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

Sexually transmitted diseases

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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

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PubMed • 2025

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

Florida public health review

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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.

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PubMed • 2025

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

Microbiology spectrum

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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.

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

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PubMed • 2025

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 sof-form 55 methafilcon a lens used for?

It is used for correcting refractive errors such as myopia and hyperopia.

What specialties typically use this device?

Optometrists and ophthalmologists typically use this device for vision correction.

What are the FDA-cleared indications?

The lens is indicated for vision correction in patients with refractive errors like nearsightedness and farsightedness.

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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