# K021566: Infiniti

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Jul 2, 2002 after 50 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844373 (1985). 11 ancestors in all.
50 later devices descend from it; 10 cite it directly.
0 of 62 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.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.
- K980292: Cataract Liquefracture Device, Alcon Laboratories (1998) Summary page 1.
- K925631: Phacotron Gold Multifunction Ultrasonic Handpiece, Chiron Intraoptics (1993) Summary page 1.

## Most influential descendants
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own
- K082473: Bausch & Lomb Stellaris Microsurgical System (2009), 22 descendants of its own
- K091777: Alcon Ultrachopper (2009), 20 descendants of its own

## Recalls of this device
- Jun 28, 2023 · Class II · Z-2408-2023: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
- Jul 28, 2016 · Class II · Z-2834-2016: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
- Oct 6, 2014 · Class II · Z-1597-2016: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

## Indications for use
The intended use of this device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

Source page: https://510kreport.com/device/K021566
Methodology: https://510kreport.com/methodology