# K182249: Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Nov 30, 2018 after 102 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: 8 generations back to P810005 (1981). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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 4.
- K160803: Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens, CooperVision, Inc. (2016) Summary page 4.

## Indications for use
The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism 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. DISPOSABLE WEAR When prescribed for Disposable Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, is to be discarded after each removal.

Source page: https://510kreport.com/device/K182249
Methodology: https://510kreport.com/methodology