PMA · Approved
ApprovedSoftcon (Vifilcon a) Soft Contact Ext Wear Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · LPM Lenses, Soft Contact, Extended Wear
Approved on Mar 31, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 364-day review. 28 later devices descend from it.
- Decided
- Mar 31, 1983
- Review
- 364 days
- Class
- Class III
- Product code
- LPM
- Recalls
- None
28 later devices descend from it, 2 citing it directly.
- This deviceP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- Descendant · cites it directly · 26 of its ownK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- Descendant · 2 generations on · 22 of its ownK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- Descendant · 2 generations on · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- Descendant · 2 generations on · 12 of its ownK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
- Descendant · 2 generations on · 11 of its ownK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · cites it directly26descendants
- K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999 · 2 generations on22descendants
- K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · 2 generations on21descendants
- K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation · 2003 · 2 generations on12descendants
- K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| +1 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| +2 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| +2 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| +2 | K033701 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft… | Ciba Vision Corporation | 2003 | — |
| +2 | K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives | Ciba Vision Corporation | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K963487 (Ciba Vision Corporation, 1996) has gone furthest, with 26 descendants of its own.
How does its category compare?
All LPM devicesLPM Lenses, Soft Contact, Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPM
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPM
Too few LPM 510(k)s in any year since 2007 to give a median.
Recalls per year · LPM
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPM
111in 2025
MAUDE reports naming product code LPM, 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 | 4 | — | 1 | 68 |
| 2008 | 15 | — | 0 | 42 |
| 2009 | 12 | — | 0 | 56 |
| 2010 | 30 | — | 3 | 108 |
| 2011 | 51 | — | 0 | 155 |
| 2012 | 49 | — | 0 | 181 |
| 2013 | 31 | — | 0 | 172 |
| 2014 | 26 | — | 3 | 111 |
| 2015 | 35 | — | 0 | 143 |
| 2016 | 43 | — | 0 | 220 |
| 2017 | 79 | — | 1 | 215 |
| 2018 | 59 | — | 1 | 195 |
| 2019 | 55 | — | 0 | 189 |
| 2020 | 45 | — | 0 | 107 |
| 2021 | 28 | — | 0 | 103 |
| 2022 | 40 | — | 0 | 82 |
| 2023 | 15 | — | 0 | 118 |
| 2024 | 31 | — | 0 | 163 |
| 2025 | 31 | — | 0 | 111 |
| 2026 | 23 | — | 0 | — |
https://510kreport.com/device/P820021 · printed Nov 5, 2026
Cite this page
510(k) Report. “P820021: Softcon (Vifilcon a) Soft Contact Ext Wear Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P820021
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026