# K232921: DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Nov 16, 2023 after 58 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962804 (1996). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric, Ciba Vision Corporation (2012) Summary page 5.

## Most influential descendants
- K243909: Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (2025), 1 descendant of its own
- K254052: DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (2026), 0 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-3313-2024: Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these l

## Indications for use
DAILIES TOTAL 1® (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. DAILIES TOTAL 1® Torie (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. DAILIES TOTAL 1® Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. DAILIES TOTAL 1® Multifocal Torie (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K232921
Methodology: https://510kreport.com/methodology