# K233856: Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Dec 29, 2023 after 24 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: 6 generations back to P810005 (1981). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182902: Precision1, Alcon Laboratories, Inc. (2018) Summary page 4.
- K230785: Precision1, Precision1 for Astigmatism, Alcon Laboratories, Inc. (2023) Summary page 4.
- K210436: Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere, Alcon Laboratories, Inc. (2021) Summary page 4.

## 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
Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism. Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. TOTAL30 (lehfilcon A) spherical 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. TOTAL30 for Astigmatism (lehfilcon A) toric 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. TOTAL30 Multifocal (lehfilcon 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. TOTAL30 lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.

Source page: https://510kreport.com/device/K233856
Methodology: https://510kreport.com/methodology