Adypi (Etafilcon A) Hydrophilic Contact Lens
by Hanita Contact Lens Laboratory
PMA P870019
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870019 | Date11 Dec 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- 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
- S002 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Adypi (Etafilcon A) Hydrophilic Contact Lens is a soft contact lens designed for daily wear, intended to correct refractive errors and improve visual acuity. Manufactured from etafilcon A, a hydrophilic material, it provides comfort and clarity for extended daily use while maintaining moisture retention on the eye.
These lenses are supplied as single-use, disposable contact lenses and are regulated under FDA Premarket Approval (PMA) as a Class 2 device. They are intended for ophthalmic use and must be handled, stored, and disposed of according to manufacturer guidelines to ensure sterility and safety. The product is authorized under PMA number P870019 and falls under product code LPL.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses reusable, or are they meant to be discarded after each use?
The Adypi (Etafilcon A) Hydrophilic Contact Lens is explicitly designed as a single-use, disposable product. This means each lens is intended for one-time wear and should be discarded after removal, following the manufacturer’s guidelines to maintain safety and sterility.
What materials are these lenses made from, and how does that affect their performance?
These lenses are manufactured from etafilcon A, a hydrophilic material that retains moisture, providing comfort and clarity for extended daily wear. The hydrophilic nature helps maintain hydration on the eye, reducing dryness during use.
How should I store these lenses to ensure they remain safe and effective?
Since these are single-use, sterile lenses, they must be stored according to the manufacturer’s instructions to preserve sterility. Typically, this involves keeping them in a sealed, dry environment away from moisture or contamination until use. Always follow the provided packaging guidelines.
What regulatory pathway was followed for this product, and what does that mean for its use?
The Adypi (Etafilcon A) Hydrophilic Contact Lens was authorized through the FDA Premarket Approval (PMA) process, classified as a Class 2 device under product code LPL. This means it underwent rigorous review to ensure safety and effectiveness for correcting refractive errors and improving visual acuity in daily wear.