Infiniti Vision System
510(k) K120912
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120912 | Date15 Jun 2012 | StatusActive |
Recalls
-
- Terminated Z-0506-2015
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Infiniti(R) Vision System
- 510(k) Number
- FDA Product Code
- HQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Infiniti Vision System is a phacoemulsification unit designed for emulsification, separation, and removal of cataracts, as well as residual cortical material and lens epithelial cells. It also facilitates vitreous aspiration, cutting for anterior vitrectomy, bipolar coagulation, and intraocular lens injection, serving as a comprehensive tool for cataract and anterior segment surgery.
This device is supplied as a reusable medical instrument and is intended for use in sterile operating room environments. It is classified under FDA product code HQC (Unit, Phacofragmentation) and has received FDA 510(k) clearance (K120912) as substantially equivalent. The system is regulated under 21 CFR 886.4670 and is manufactured by Alcon Manufacturing, Ltd.
Other devices from Alcon Manufacturing, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the Infiniti Vision System designed to assist with in the operating room?
The Infiniti Vision System is specifically designed for cataract surgery, including emulsification, separation, and removal of cataracts, residual cortical material, and lens epithelial cells. It also supports vitreous aspiration, anterior vitrectomy cutting, bipolar coagulation, and intraocular lens injection, making it a versatile tool for both cataract and anterior segment surgeries.
Is the Infiniti Vision System intended for single-use or reusable applications in the operating room?
The Infiniti Vision System is supplied as a reusable medical instrument, meaning it is intended for use in sterile operating room environments after proper cleaning, sterilization, and maintenance procedures.
What regulatory pathway was followed for the FDA clearance of the Infiniti Vision System?
The Infiniti Vision System received FDA 510(k) clearance under the traditional review pathway, with a decision date of June 15, 2012. It was determined to be substantially equivalent to a legally marketed predicate device and is classified under FDA product code HQC (Unit, Phacofragmentation).
Are there multiple models or configurations available for the Infiniti Vision System, and how would one identify them?
Yes, the Infiniti Vision System includes multiple configurations or models, each identified by a unique FEI number (e.g., 1000120314, 3006695864, etc.). These variations may correspond to different features or specifications, but the core function remains consistent for phacoemulsification and related procedures.