510(k) · Cleared
ClearedUltra (samfilcon A) Multifocal for Astigmatism Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 30, 2018 as substantially equivalent to K131208 (Bausch & Lomb, Inc., 2013) and 1 other predicate after a 102-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Nov 30, 2018
- Review
- 102 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to P810005 (1981). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 7 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 6 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 5 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 4 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 3 generations backK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- 2 generations backK113759 Avaira (Enfilcon a) Contact LensCooperVision, Inc. · 2012 · Recalled
- 1 generation backK160803 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · Recalled
- This deviceK182249 Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −7 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −6 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −5 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −4 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −3 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| −2 | K113759 | Avaira (Enfilcon a) Contact Lens | CooperVision, Inc. | 2012 | 1 |
| −1 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | 2016 | 1 |
| 0 (this device) | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb, Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Summary page 4…LPL Predicate Device: The predicate devices are x Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses cleared under K131208, and x Coopervision, Inc., Avaira Vitality (fanfilcon A) Multifocal Toric Soft (hydrophilic) Contact Lens clea… | 2013 |
| * | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensSummary page 4…Lenses cleared under K131208, and x Coopervision, Inc., Avaira Vitality (fanfilcon A) Multifocal Toric Soft (hydrophilic) Contact Lens cleared under K160803. Device Description: The Bausch + Lomb (samfilcon A) Multifocal for Astigmatism Contact Lens is 46% water and 54% samfilcon A m… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 8 of the 21 ancestors have a recall of any class.
- 5 other devices also cite its predicate K131208.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182249: Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182249
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026