# K113703: Bausch + Lomb Nesofilcon a Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Jun 5, 2012 after 172 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 K974780 (1998). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens, Bausch & Lomb (2006) Summary page 1.

## Most influential descendants
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens (2013), 3 descendants of its own
- K200528: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism (2020), 2 descendants of its own
- K210975: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2021), 1 descendant of its own
- K143632: Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens (2015), 1 descendant of its own
- K220613: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2023), 0 descendants of its own

## Recalls of this device
- Sep 3, 2015 · Class II · Z-0206-2016: The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

## Indications for use
Bausch +.Lomb nesofilcon A contact lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.000 to -20.OOD. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Source page: https://510kreport.com/device/K113703
Methodology: https://510kreport.com/methodology