# K101285: Constellation Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Manufacturing, Ltd.
- Decided: Nov 12, 2010 after 189 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933880 (1994). 40 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063583: Alcon Vision System, Alcon (2008) Summary page 1.
- K091777: Alcon Ultrachopper, Alcon Research, Ltd. (2009) Summary page 1.
- K093305: Enhanced Ultra Vit Probe, Alcon Research, Ltd. (2010) Summary page 1.
- K062624: Next Generation Laser, Alcon Laboratories (2007). Our reading of the summary gave K062604, FDA’s number for Rapidteg Teg-Act Test (Haemoscope Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Next Generation Laser”.

## Most influential descendants
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K161794: CENTURION Vision System (Active SentryTM) (2017), 3 descendants of its own
- K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula (2011), 3 descendants of its own
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own

## Recalls of this device
- 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
- Jul 25, 2018 · Class II · Z-1794-2020: There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
- Jan 12, 2018 · Class II · Z-0778-2018: Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOT
- Jan 12, 2018 · Class II · Z-0779-2018: Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOT

## Indications for use
The Constellation® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

Source page: https://510kreport.com/device/K101285
Methodology: https://510kreport.com/methodology