Identity
- Trade Name
- OPTACRYL II BLUE FDA PMA
- Generic Name
- Lens, contact (other material) - daily FDA PMA
Identifiers
- PMA Number
- P820056 FDA PMA
- FDA Product Code
- HQD FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5916 FDA PMA
- Regulation Number
- 886.5916 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S010 FDA PMA
The Optacryl 60 Clear is a daily-use contact lens made from an alternative material, designed for ophthalmic applications. It falls under the classification of a contact lens intended for single-day wear, providing temporary vision correction or refractive management without prolonged ocular contact.
This device is supplied as a single-use product, intended for sterile application to the eye. It is classified as a Class II medical device under FDA regulations (886.5916) and holds a Premarket Approval (PMA P820056) from the FDA. Available in various sizes and configurations, it must be stored in a clean, dry environment as per manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What is the primary purpose of the Optacryl 60 Clear contact lens, and how does it differ from other daily-use lenses?
The Optacryl 60 Clear is designed for temporary vision correction or refractive management, intended for single-day wear only. Unlike some other daily-use lenses, it is made from an alternative material, which may offer distinct properties like comfort or oxygen permeability. Since it is not meant for prolonged ocular contact, it is specifically engineered for short-term use, ensuring safety and performance for one day per lens.
Are these lenses reusable, or are they meant for single-use only? How should they be stored to maintain sterility?
The Optacryl 60 Clear is explicitly labeled as a single-use contact lens, meaning each lens is intended for one-time wear only. To preserve sterility and performance, they must be stored in a clean, dry environment as directed by the manufacturer. Avoiding moisture or contamination is critical, as reuse is not supported by the design or regulatory classification.
What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?
The Optacryl 60 Clear underwent a Premarket Approval (PMA) process through the FDA, with the approval number P820056. This means the device has undergone rigorous review to ensure safety and effectiveness for its intended use—temporary vision correction or refractive management in daily wear. Clinicians can rely on this approval as evidence of the device’s compliance with FDA standards for Class II medical devices.
How many different sizes or configurations are available for the Optacryl 60 Clear, and what does this mean for patient fitting?
The Optacryl 60 Clear is available in multiple sizes and configurations, as indicated by the diverse FEI numbers listed in the regulatory data. This variety allows for better customization to fit different prescription needs and corneal shapes, improving comfort and vision correction for a broader range of patients. Optometrists can select the appropriate size based on individual patient requirements.
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 | P820056 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA PMA P820056 23 fields · synced Sep 18, 2026