đź“Š Evidence-Based Reference
bausch lomb ultra samfilcon a visibility tinted soft hydrophilic contact lens
Bausch And Lomb, Inc.,
Summary: The Bausch Lomb Ultra Samfilcon A is a visibility tinted soft hydrophilic contact lens designed for presbyopia vision correction. It is FDA PMA cleared and supported by 8 studies, focusing on comfort and optical performance.
FDA Clearance Information
Pathway
PMA
Number
P170035 ↗
Decision Date
June 1, 2022
Product Code
LPM
Device Class
Class 3
Evidence
419 studies
The Bausch Lomb Ultra Samfilcon A was cleared by the FDA via the PMA pathway on June 1, 2022. It is manufactured by Bausch And Lomb, Inc. and classified as a Class 3 medical device.
What It Is
The Bausch Lomb Ultra Samfilcon A is a silicone hydrogel contact lens designed to correct presbyopia. It features a visibility tint and is intended for daily wear, providing enhanced comfort and optical performance.
Clinical Applications
This device is commonly used in patients with presbyopia who require vision correction. It is suitable for individuals seeking a comfortable and effective contact lens solution for daily use.
Evidence Summary
The available literature includes 8 studies, comprising randomized controlled trials and other study types, conducted between 2020 and 2022. These studies primarily focus on comfort, optical performance, and the impact of external factors like cosmetics.
Reported Outcomes
Published studies report that the Bausch Lomb Ultra Samfilcon A lenses provide satisfactory comfort and optical performance. Comparative studies indicate favorable outcomes in terms of tear film stability and user satisfaction.
Safety Profile
Reported complications include potential exposure to cosmetics affecting lens integrity and optical properties. No severe adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and short duration of some studies. Further research is needed to assess long-term safety and performance in diverse populations.
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 are the clinical indications for Bausch Lomb Ultra Samfilcon A?
The device is indicated for presbyopia vision correction using a new power measurement method on the Spin-Blot System.
What outcomes have been reported in clinical studies?
Studies report satisfactory comfort and optical performance, with favorable outcomes in tear film stability and user satisfaction.
What complications have been reported?
Reported complications include potential exposure to cosmetics affecting lens integrity and optical properties, with no severe adverse events noted.
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.