PMA · Approved
ApprovedPure Vision Visibility Tinted Contact Lens for Extended Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LPM Lenses, Soft Contact, Extended Wear
Approved on Feb 5, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 336-day review. 14 later devices descend from it.
- Decided
- Feb 5, 1999
- Review
- 336 days
- Class
- Class III
- Product code
- LPM
- Recalls
- None
14 later devices descend from it, 1 citing it directly.
- This deviceP980006 Pure Vision Visibility Tinted Contact Lens for Extended WearBausch & Lomb, Inc. · 1999
- 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 · 2 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- Descendant · 3 generations on · 1 of its ownK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK223585 Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 2 generations on3descendants
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd. · 2024 · 3 generations on1descendant
- K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P980006 | Pure Vision Visibility Tinted Contact Lens for Extended Wear | Bausch & Lomb, Inc. | 1999 | — |
| +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 | — |
| +2 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| +3 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
| +3 | K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens… | Yung Sheng Optical Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (14)
See all 141 later device cites 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 |
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, K050948 (Bausch & Lomb, Inc., 2005) has gone furthest, with 13 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/P980006 · printed Nov 5, 2026
Cite this page
510(k) Report. “P980006: Pure Vision Visibility Tinted Contact Lens for Extended Wear.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P980006
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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