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
Number ?
P890040 ↗
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.
FDA-Cleared Indications
- Correction of refractive errors, including myopia and hyperopia.
Clinical Applications
- Daily-wear vision correction when prescribed and fitted by an eye-care professional.
- Correction of nearsightedness (myopia).
- Correction of farsightedness (hyperopia).
- Outpatient contact-lens fitting for patients whose eye health and prescription are appropriate for this lens.
Practical Considerations
- The lens must be fitted by an optometrist or ophthalmologist using the patient's prescription, corneal measurements, and eye-health assessment.
- Available parameters, including diameter, base curve, and prescription range, depend on the manufacturer's approved labeling and inventory.
- Patients should follow the prescribed wearing schedule, cleaning instructions, replacement schedule, and hand-hygiene requirements.
- Contact lenses should not be worn with eye infection, significant irritation, or other contraindications identified by the prescribing clinician.
- MRI safety is generally not a concern for nonmetallic soft contact lenses, but the lens should be removed if it contains or may contain metallic components or if the imaging facility requires removal.
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 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.