# K063583: Alcon Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon
- Decided: May 9, 2008 after 526 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K844373 (1985). 14 ancestors in all.
36 later devices descend from it; 7 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 1.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.
- K032598: Synergetics Synerlight Fiber Optic Lightsource, Synergetics, Inc. (2003) Summary page 1.

## Most influential descendants
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own
- K091777: Alcon Ultrachopper (2009), 20 descendants of its own
- K093305: Enhanced Ultra Vit Probe (2010), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K102727: Lensar Laser System for Anterior Capsulotomy (2011), 12 descendants of its own

## Recalls of this device
- Apr 30, 2010 · Not classified · Z-1933-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1927-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1925-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1931-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1924-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1929-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1934-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1930-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1928-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1926-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui
- Apr 30, 2010 · Not classified · Z-1932-2010: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and flui

## Indications for use
The Alcon 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/K063583
Methodology: https://510kreport.com/methodology