📋 FDA Reference
Smart Performer 55 Ocufilcon D Soft Hydrophilic Contact Lens
Smart Performer Corp.
Summary: The Smart Performer 55 Ocufilcon D is a soft hydrophilic contact lens used for vision correction. It is primarily utilized by optometrists and ophthalmologists for patients requiring contact lenses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152657 ↗
Decision Date ?
May 17, 2016
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Smart Performer 55 Ocufilcon D lens was cleared through the FDA's 510k pathway on May 17, 2016. Manufactured by Smart Performer Corp., it is classified as a Class 2 medical device under product code LPL.
What It Is
The Smart Performer 55 Ocufilcon D is a soft contact lens made from a hydrophilic material, ocufilcon D, designed to correct refractive errors in the eye. These lenses are intended to be worn on the cornea and provide a comfortable fit due to their water-absorbing properties. They are typically used for daily wear and can be a convenient alternative to glasses for many patients.
FDA-Cleared Indications
- Correction of refractive errors with a soft hydrophilic contact lens.
- Use on the cornea for vision correction in patients prescribed contact lenses.
- Use in daily-wear contact lens applications when prescribed and fitted by an eye-care professional.
Clinical Applications
- Vision correction for myopia, or nearsightedness, when included in the prescribed lens parameters.
- Vision correction for hyperopia, or farsightedness, when included in the prescribed lens parameters.
- Correction of astigmatism when an appropriate lens design and prescription are available.
- Daily-wear use as an alternative to eyeglasses under professional fitting and follow-up.
Practical Considerations
- The lens must be fitted and prescribed by an optometrist or ophthalmologist; available parameters, base curves, diameters and powers should be confirmed in the product labeling.
- Follow the prescribed wearing schedule and cleaning or disinfecting instructions. Do not use tap water or saliva to clean or store contact lenses.
- Patients with eye infection, significant inflammation, unexplained redness or pain should remove the lens and seek professional evaluation.
- Contact lenses are not evaluated as MRI implants and generally do not require MRI precautions; the lens should be removed if advised by the imaging facility or eye-care professional.
- Proper hand hygiene, replacement at the prescribed interval and routine eye examinations are important because improper use can increase the risk of corneal injury or infection.
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 Smart Performer 55 Ocufilcon D used for?
It is used for correcting refractive errors such as myopia, hyperopia, and astigmatism in patients who prefer contact lenses over glasses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practice for vision correction.
What are the FDA-cleared indications?
The lenses are indicated for correcting refractive errors in patients who require vision 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.