# K141065: Constellation Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Aug 22, 2014 after 120 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933880 (1994). 60 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101285: Constellation Vision System, Alcon Manufacturing, Ltd. (2010) Summary page 5.
- K063583: Alcon Vision System, Alcon (2008) Summary page 5.
- K121555: Centurion Vision System, Alcon Laboratories, Inc. (2012) Summary page 5.
- K120912: Infiniti (R) Vision System, Alcon Manufacturing, Ltd. (2012) Summary page 5.
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece, Alcon Manufacturing, Ltd. (2011) Summary page 6.
- K082845: Infiniti Vision System with Ozil IP, Alcon Research, Ltd. (2009) Summary page 6.
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 6.
- K091777: Alcon Ultrachopper, Alcon Research, Ltd. (2009) Summary page 6.

## Most influential descendants
- K233876: Unity VCS (8065000296); Unity CS (8065000297) (2024), 0 descendants of its own
- K193376: Visalis V500, Visalis S500 (2020), 0 descendants of its own

## Recalls of this device
- Aug 5, 2025 · Class II · Z-0304-2026: Due to incomplete seals in the pouch which provide the sterile barrier.
- Aug 5, 2025 · Class II · Z-0305-2026: Due to incomplete seals in the pouch which provide the sterile barrier.
- Apr 28, 2025 · Class II · Z-2108-2025: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is v
- Apr 28, 2025 · Class II · Z-2109-2025: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is v
- Aug 18, 2023 · Class II · Z-0099-2024: Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure cont
- Jun 28, 2023 · Class II · Z-2406-2023: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

## Indications for use
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. Flex-Tip Laser Probes • Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative retinopathy (including diabetic); o Choroidal neovascularization secondary to age-related macular degeneration; o Retinal tears and detachments; o Macular edema; o Retinopathy of prematurity; o Choroidal neovascularization; o Leaking microaneurysms. • Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. • Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. • And other laser treatments including: o Internal sclerostomy; o Lattice degeneration; o Central and Branch Retinal Vein Occlusion; o Suturelysis; o Vascular and pigmented skin lesions. UltraVit Probes • Vitreous aspiration & cutting. • Membrane cutting & aspiration. • Lens removal. Endoilluminator Probes • Endoillumination Valved Entry Systems • Scleral incision • Canulae for posterior segment instrument access • Venting (of valved cannulae) Infusion Cannulas • Posterior segment infusion (liquid or gas)

Source page: https://510kreport.com/device/K141065
Methodology: https://510kreport.com/methodology