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FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P850077 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The device is a Lenses, soft contact, extended wear, designed for prolonged corneal contact without removal. These lenses are made from methafilcon A, a hydrophilic material, and are intended for continuous or extended wear to correct refractive errors while maintaining ocular comfort and health.
These lenses are supplied as single-use or disposable, depending on the specific model, and are regulated under FDA Premarket Approval (PMA) as a Class III device. They are not MRI-safe unless explicitly stated in the product documentation, and storage conditions must adhere to manufacturer guidelines to preserve sterility and performance. Authorized under PMA number P850077, these lenses are distributed under the product code LPM and are intended for ophthalmic use only.
Frequently asked questions
Are these contact lenses designed for overnight wear, and if so, how do they differ from daily-wear options?
Yes, these lenses are specifically designed for extended wear, meaning they are approved for continuous corneal contact without removal for prolonged periods—unlike traditional daily-wear lenses that require removal at night. Made from methafilcon A, a hydrophilic material, they prioritize corneal oxygen permeability and comfort during extended use while correcting refractive errors. The extended-wear design allows for greater convenience but requires strict adherence to manufacturer guidelines for wear schedules and care to maintain ocular health.
Are these lenses single-use or reusable, and how should they be stored to maintain sterility?
These lenses are supplied as single-use or disposable, depending on the specific model within the SUNSOFT (methafilcon A) series. To preserve sterility and performance, storage must follow the manufacturer’s guidelines, which typically include keeping them in a sealed, sterile packaging until use and avoiding contamination. Unlike reusable lenses, these are not intended for multiple wears, reducing the risk of infection or damage over time.
Can these lenses be used safely in an MRI environment, and what safety precautions should be taken?
These lenses are not inherently MRI-safe unless explicitly stated in the product documentation for a particular model. If MRI imaging is required, the patient should confirm with the manufacturer whether the specific lens variant is safe for use in an MRI environment. If not, the lenses must be removed before the procedure, as metal or conductive materials in the lens could pose risks during magnetic resonance imaging.
What regulatory pathway was followed for approval, and how does this affect their use in clinical settings?
These lenses were approved through the FDA Premarket Approval (PMA) process, classified as a Class III device due to their extended-wear design and direct contact with the cornea. This rigorous pathway ensures their safety and effectiveness for prolonged use. Clinically, this means they are subject to strict manufacturing controls, labeling requirements, and post-market surveillance to maintain compliance with FDA standards. The approval number is P850077, and they are distributed under product code LPM for ophthalmic use only.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P850077 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P850077 24 fields · synced Sep 18, 2026