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Tangible Hydrogel with Tangible Polymer Etafilcon a Soft Hydrophilic Daily Disposable Contact Lens
Tangible Science
Summary: The tangible hydrogel contact lens is a daily disposable lens designed for hydrophilic use. It is FDA-cleared and supported by studies focusing on its biocompatibility and clinical applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172692 ↗
Decision Date ?
December 13, 2017
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The tangible hydrogel contact lens by Tangible Science was cleared via the FDA 510k pathway on December 13, 2017. It is classified as a Class 2 medical device.
What It Is
This device is a soft hydrophilic contact lens made from etafilcon A, designed for daily disposable use. It leverages hydrogel technology to enhance comfort and biocompatibility for users.
FDA-Cleared Indications
- Daily wear as a soft hydrophilic contact lens for vision correction.
- Daily disposable use, with removal and disposal after each day of wear.
Clinical Applications
- Daily vision correction for patients who require a soft hydrophilic contact lens.
- Use as a single-use daily disposable lens rather than overnight wear.
- Routine contact lens wear when the prescribing eye-care professional determines that an etafilcon A lens is appropriate.
Evidence Summary
The literature includes four studies, with types ranging from RCTs to reviews, published between 2019 and 2025. These studies explore the material's applications and performance.
Reported Outcomes
Published studies report that hydrogels, including those used in this lens, offer improved biocompatibility and comfort. However, challenges such as mechanical strength and controlled release remain areas of ongoing research.
Safety Profile
Reported complications include issues related to mechanical strength and potential for irreversible chain breakage, which may affect the lens's long-term efficacy.
Evidence Limitations
The evidence is limited by a lack of specific clinical trials directly assessing the lens's performance. Further research is needed to address mechanical strength and controlled release capabilities.
Practical Considerations
- The lens is intended for daily wear and should not be worn overnight unless the specific labeling and eye-care professional instructions allow it.
- Each lens should be handled with clean, dry hands and discarded after use; it should not be reused or stored for another day.
- The correct base curve, diameter, power and fit depend on the specific product configuration and must be selected by an eye-care professional.
- Do not use the lens with eye infection, significant eye inflammation or unexplained eye pain, redness or vision changes; remove it and seek professional advice if these symptoms occur.
- This is a contact lens, not an implanted device, so MRI compatibility is generally not a relevant safety issue.
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 tangible hydrogel contact lens?
The lens is indicated for daily disposable use in patients requiring hydrophilic contact lenses for improved comfort and hydration.
What outcomes have been reported in clinical studies?
Studies report enhanced biocompatibility and comfort, though mechanical strength remains a challenge.
What complications have been reported?
Safety data indicate potential issues with mechanical strength and irreversible chain breakage.
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.