Osprey Spherical and Toric Multifocal Soft Contact Lenses
by Florida Optical Engineering, Inc.
510(k) K013445
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013445 | Date26 Dec 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Osprey Spherical and Toric Multifocal Soft Contact Lenses are center-distance, simultaneous-focus, progressive-addition soft contact lenses designed for daily wear. These lenses are manufactured from hioxifilcon B polymer blanks and provide multifocal correction for presbyopia, enabling clear vision at multiple distances. Spherical versions offer general multifocal correction, while toric versions incorporate superior/inferior front surface flanges for axis stabilization, addressing both astigmatism and presbyopia.
These lenses are intended for patient-maintained use, requiring cleaning and disinfection as part of daily wear. Supplied as single-use or reusable depending on the specific prescription, they are regulated under FDA 510(k) clearance (K013445) as Class II devices (Product Code: LPL). They are not MRI-safe or sterile upon packaging and must be handled according to standard ophthalmic contact lens care protocols. Multiple FEI numbers (e.g., 3015533540) correspond to registered variants, including different prescriptions and visibility tints.
Questions
AI-generated answers, 19 Sep 2026
Are these contact lenses designed for continuous wear, or are they meant for daily wear only?
The Osprey Spherical and Toric Multifocal Soft Contact Lenses are explicitly designed for daily wear only, requiring cleaning and disinfection as part of routine use. They are not intended for continuous or extended wear beyond the manufacturer’s specified daily use guidelines.
Do these lenses come in single-use or reusable options, and how should they be handled?
These lenses are supplied either as single-use or reusable, depending on the specific prescription variant. Since they are not sterile upon packaging, they must be handled according to standard ophthalmic contact lens care protocols, including proper cleaning and disinfection before and after each use.
Are these lenses safe to use in an MRI environment, and what precautions should be taken?
The Osprey Spherical and Toric Multifocal Soft Contact Lenses are not MRI-safe. If MRI imaging is required, the lenses must be removed beforehand, as they are not designed to withstand magnetic fields. Always follow facility protocols for non-MRI-safe devices during imaging.
How do I determine which prescription variant or FEI number corresponds to my patient’s specific needs?
The Osprey lenses come in multiple FEI (Firm Establishment Identification) numbers, each corresponding to different prescriptions, visibility tints, and lens designs (spherical or toric). To match a patient’s needs, consult the manufacturer’s catalog or a dispensing optometrist, as the correct variant depends on the patient’s refractive error, astigmatism, and vision correction requirements.
What material are these lenses made from, and how does that affect their performance?
These lenses are manufactured from hioxifilcon B polymer, a material designed for soft contact lenses. This polymer provides the necessary oxygen permeability and comfort for daily wear while enabling simultaneous-focus correction for presbyopia. The material choice supports clear vision at multiple distances without compromising lens durability or patient comfort.