510(k) · Cleared
ClearedBausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 16, 2002 as substantially equivalent to K960926 (Unilens Corp., USA, 1996) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1996. 26 later devices descend from it.
- Decided
- May 16, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960926 (1996). 2 ancestors in all. 26 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- This deviceK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- Descendant · cites it directly · 13 of its ownK050948 Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK131208 Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb…Bausch & Lomb, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
- Descendant · 2 generations on · 3 of its ownK143052 Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005 · cites it directly13descendants
- K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc. · 2013 · 2 generations on9descendants
- K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. · 2013 · cites it directly6descendants
- K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd. · 2014 · 2 generations on3descendants
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| 0 (this device) | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| +1 | K050948 | Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 2005 | — |
| +2 | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort… | Bausch & Lomb, Inc. | 2013 | — |
| +1 | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2013 | — |
| +2 | K143052 | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens… | Yung Sheng Optical Co., Ltd. | 2014 | — |
| +2 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensSummary page 1…ibility Tinted Contact Lens Predicf;ate Devices: i . Optima™ FW (polymacon) Visibility Tinted Contact Lens (N16-895) Unilens EMA (polymacon) Soft Bifocal Contact Lens (K960926) Acuvue Bifocal (etafilcon A) Contact Lens (K962804) 4. DESCRIPTION OF DEVICE The BAUSCH & LOMB® Softens™ MultiF… | 1996 |
| * | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerSummary page 1…. Optima™ FW (polymacon) Visibility Tinted Contact Lens (N16-895) Unilens EMA (polymacon) Soft Bifocal Contact Lens (K960926) Acuvue Bifocal (etafilcon A) Contact Lens (K962804) 4. DESCRIPTION OF DEVICE The BAUSCH & LOMB® Softens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a… | 1996 |
| * | — | Optima™ FW (polymacon) Visibility Tinted Contact Lens Named without a submission number |
What descends from it? (26)
See all 264 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050948 | Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens | 2005 | 13 |
| K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear | 2013 | 6 |
| K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses | 2013 | 2 |
| K082883 | Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear | 2009 | 1 |
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?
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.
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?
BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted 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 2.00 diopters or less, that does not interfere with visual acuity The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to…
Read the full statement (130 words)
BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted 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 2.00 diopters or less, that does not interfere with visual acuity The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted 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/K020927
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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