# K230954: Samfilcon B Custom Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch + Lomb, Incorporated
- Decided: Nov 17, 2023 after 227 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960926 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,, Bausch & Lomb, Inc. (2013) Summary page 5.
- K091327: Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54  Toric Multifocal Contact Lenses, Alden Optical Labs., Inc. (2010) Summary page 5.

## Indications for use
Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia and/or astigmatism) in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters. Bausch + Lomb Samfilcon B Contact Lens for Presbyopia for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. Bausch + Lomb Samfilcon B Contact Lens Multifocal for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters. When prescribed for frequent planned replacement wear, the contact lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system. The Samfilcon B Contact Lens is available for a frequent/planned replacement modality.

Source page: https://510kreport.com/device/K230954
Methodology: https://510kreport.com/methodology