Disposable Vitrectomy Sets, Disposable Virectomy Lenses
by Fci Ophthalmics, Inc. 510(k)
Active
510(k) K030054
Overview
This device comprises disposable vitrectomy sets and disposable vitrectomy lenses, classified as contact lenses, diagnostic, polymethylmethacrylate under FDA nomenclature. Designed for vitreoretinal surgery, these single-use components facilitate high-resolution visualization of the posterior pole, fundus, and peripheral retina, including specialized optics such as plano-concave, autostable plano-concave, 30° prismatic, and biconcave configurations for targeted retinal examination and emulsification procedures.
The lenses are supplied sterile in peel packs, packaged individually and sold in boxes of 10. They are intended for single-use only and must be discarded after surgery. Regulated under FDA 510(k) clearance (K030054) as substantially equivalent to a predicate device, these components adhere to Class II medical device standards for ophthalmic use. No MRI safety or reusable variants are specified in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030054 | Date26 Feb 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1385
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fci Ophthalmics, Inc.
Questions
What are these disposable vitrectomy lenses designed for?
These lenses are specifically designed for vitreoretinal surgery to provide high-resolution visualization of the posterior pole, fundus, and peripheral retina. They include specialized optics like plano-concave, autostable plano-concave, 30° prismatic, and biconcave configurations, which are tailored for targeted retinal examination and emulsification procedures.
How are the lenses supplied and packaged?
The lenses are supplied sterile in peel packs, with each lens individually packaged. They are sold in boxes containing 10 lenses, ensuring sterility and ease of use for surgical procedures.
Are these lenses intended for single-use or reuse?
These lenses are explicitly intended for single-use only. After use in surgery, they must be discarded to maintain sterility and prevent cross-contamination.
What materials are the lenses made from?
The lenses are made from polymethylmethacrylate (PMMA), a material commonly used in diagnostic contact lenses for ophthalmic applications.
How should these lenses be stored?
The lenses should be stored in their original sterile packaging (peel packs) within the sealed box until ready for use. Ensure the storage environment is clean, dry, and protected from direct sunlight or extreme temperatures to preserve sterility and functionality.