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Cooper Tm 38 Polymacon Hydrophilic Contact Lens
Coopervision
Summary: The Cooper TM 38 Polymacon Hydrophilic Contact Lens is a soft contact lens used for vision correction. It is primarily used by optometrists and ophthalmologists for patients requiring refractive correction.
FDA Clearance Information
Pathway ?
PMA
Number ?
P810057 ↗
Decision Date ?
March 28, 1991
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA premarket approval (PMA) pathway on March 28, 1991. Manufactured by Coopervision, it is classified as a Class 2 medical device.
What It Is
The Cooper TM 38 Polymacon Hydrophilic Contact Lens is a soft contact lens made from polymacon, a hydrophilic material that retains moisture to enhance comfort. It is designed to correct refractive errors such as myopia and hyperopia by focusing light directly onto the retina. The lens is intended for daily wear and is available in various prescriptions to accommodate different levels of vision correction.
FDA-Cleared Indications
- Correction of myopia, or nearsightedness.
- Correction of hyperopia, or farsightedness.
- Vision correction with a polymacon hydrophilic soft contact lens.
Clinical Applications
- Daily-wear contact lens correction for nearsightedness.
- Daily-wear contact lens correction for farsightedness.
- Prescription vision correction for patients who prefer contact lenses to eyeglasses.
- Fitted and monitored use in optometry or ophthalmology practice.
Practical Considerations
- The lens must be prescribed and fitted by an eye-care professional; base curve, diameter and prescription should match the patient’s eye.
- Patients should follow the prescribed wearing, cleaning, disinfection and replacement schedule. Do not wear the lens while sleeping unless specifically directed by the prescriber.
- Contact lenses should not be worn with active eye infection, significant eye inflammation or other contraindications identified during an eye examination.
- The lens is worn on the cornea and does not require MRI precautions; patients should follow facility instructions and remove contact lenses if requested.
- Stop wearing the lens and seek prompt eye-care advice for eye pain, marked redness, light sensitivity, discharge or sudden vision changes.
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 the Cooper TM 38 Polymacon Contact 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.
What are the FDA-cleared indications?
The device is indicated for the correction of 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.