Ocusil Contact Lens
by O.S.I. Corp. PMA
Active
PMA P840050
Overview
The Ocusil Contact Lens is a daily-use, single-patient disposable contact lens made from other materials, as classified under the nomenclature for ophthalmic devices. It is designed for temporary corneal refractive correction and ocular surface protection, providing clear vision while maintaining comfort for short-term wear.
This device is supplied as a sterile, single-use lens intended for professional fitting by eye care practitioners in clinical or home settings. It adheres to FDA Premarket Approval (PMA) requirements under regulation number 886.5916 and is categorized as a Class II medical device. Storage and handling follow standard ophthalmic contact lens protocols to ensure sterility and performance integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP840050 | Date20 Nov 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Ocusil(Tm) Contact Lens
- Generic Name
- Lens, contact (other material) - daily
- PMA Number
- FDA Product Code
- HQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- APRL
Questions
What is the primary purpose of the OCUSIL™ Contact Lens and how does it differ from standard daily-use contact lenses?
The OCUSIL™ Contact Lens is designed specifically for temporary corneal refractive correction and ocular surface protection, offering clear vision while ensuring comfort for short-term wear. Unlike standard daily-use contact lenses, it is explicitly intended for professional fitting by eye care practitioners and emphasizes both refractive correction and protection of the ocular surface, making it suitable for clinical or home settings where temporary vision correction is needed.
Is the OCUSIL™ Contact Lens meant for reuse, or is it intended as a single-use device for one patient?
The OCUSIL™ Contact Lens is explicitly labeled as a single-use, single-patient device. This means each lens is intended for one-time wear by an individual patient only, adhering to standard ophthalmic contact lens protocols to maintain sterility and performance integrity. Reuse is not recommended or supported by the manufacturer.
How should the OCUSIL™ Contact Lens be stored to ensure sterility and proper functionality?
The OCUSIL™ Contact Lens is supplied as a sterile device, so storage must follow standard ophthalmic contact lens protocols to preserve sterility and performance. This typically includes keeping the lens in its original packaging until use, avoiding exposure to moisture or contamination, and storing it in a clean, dry environment away from direct sunlight or extreme temperatures. Always refer to the manufacturer’s instructions for specific storage guidelines.
What regulatory pathway does the OCUSIL™ Contact Lens follow, and what does this mean for clinicians or buyers?
The OCUSIL™ Contact Lens follows the FDA Premarket Approval (PMA) pathway, as indicated by its PMA number (P840050) and classification under regulation number 886.5916. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness, and it is categorized as a Class II medical device. Clinicians or buyers can rely on this approval for confidence in its regulatory compliance and intended use for temporary corneal refractive correction and ocular surface protection.
Are there multiple sizes or models available for the OCUSIL™ Contact Lens, and how would a practitioner determine the correct fit?
While the provided data lists multiple FEI numbers and registration numbers, these are administrative identifiers and do not specify distinct sizes or models in the description. The OCUSIL™ Contact Lens is designed for professional fitting by eye care practitioners, who would use standard ophthalmic measurements (such as corneal curvature and axial length) to determine the appropriate fit. The manufacturer’s instructions or consultation with an eye care professional would guide selection.