Hydracon Contact Lenses
by Hydracon
PMA P820017
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820017 | Date30 Oct 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Hydracon(R) Contact Lenses
- Generic Name
- Lenses, soft contact, daily wear
- PMA Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S009
Overview
AI-generated summary, 18 Sep 2026
This device is classified as Lenses, Soft Contact, Daily Wear, designed for corneal refractive correction. They are intended to provide clear vision by resting directly on the eye’s surface, offering a comfortable and non-invasive alternative to glasses or rigid lenses. The lenses are manufactured from hydrogel materials to ensure oxygen permeability and wearer comfort during daily use.
Hydracon Contact Lenses are supplied as single-use, non-sterile products intended for professional fitting by ophthalmic practitioners. They are regulated under FDA_PMA (PMA Number: P820017) and fall under Device Class II (Regulation Number: 886.5925). Each lens is packaged individually for hygiene and convenience, with multiple sizes available to accommodate varying prescriptions and corneal curvatures. Storage instructions specify a cool, dry environment away from direct sunlight.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for overnight wear, or are they meant for daily use only?
These lenses are explicitly labeled as daily wear, meaning they are intended for use during waking hours only and should not be worn overnight. The description specifies they are designed for corneal refractive correction while providing comfort for daily use, aligning with standard daily-wear soft contact lens guidelines.
How are the HYDRACON contact lenses packaged, and what does this mean for handling?
The lenses are supplied as single-use, individually packaged units. This packaging ensures hygiene by preventing cross-contamination between lenses and makes them convenient for one-time use per fitting. Each package is meant to be opened only once, reducing the risk of infection or damage to the lens.
Are these lenses sterile, and if not, what precautions should be taken before use?
The lenses are non-sterile as stated in the product description. Before use, they should be handled in a clean environment, and proper hygiene practices—such as washing hands and using sterile solutions—should be followed. Since they are single-use, they are intended for professional fitting by ophthalmic practitioners who can ensure proper sterilization of the eye and lens application tools.
What storage conditions are recommended for these lenses, and why?
The lenses should be stored in a cool, dry environment away from direct sunlight. This prevents degradation of the hydrogel material, which could affect oxygen permeability and lens integrity. Exposure to heat or moisture may compromise the lens’s performance and safety, so adhering to these conditions ensures longevity and effectiveness.
How do I determine if the correct size or prescription is available for a patient?
The lenses come in multiple sizes to accommodate varying prescriptions and corneal curvatures. Since the exact sizing options are not detailed in the provided data, it’s recommended to consult the manufacturer’s sizing charts or work with an ophthalmic practitioner who can measure the patient’s corneal curvature and select the appropriate lens. The product’s regulatory classification (FDA_PMA) indicates it has undergone evaluation for safety and effectiveness across these variations.