PMA · Approved
Recalled · Class II · 2020Hydrasoft (Methafilcon B) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · LPM Lenses, Soft Contact, Extended Wear
Approved on Jan 31, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 93-day review. It has been recalled 3 times.
- Decided
- Jan 31, 1986
- Review
- 93 days
- Class
- Class III
- Product code
- LPM
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P850079 has 82 supplements since 1986: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1986 | 5 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 11 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 6 |
| 2018 | 3 |
| 2019 | 6 |
| 2020 | 4 |
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2020 | Class II | Z-1227-2020 | Process control | Incorrect power of lenses than the expected |
| Jul 22, 2003 | Not classified | Z-1091-03 | Other | Mislabeled with incorrect sphere power. |
| Jun 25, 2003 | Not classified | Z-0978-03 | Other | The actual sphere power of the lens is lower than the labeled value. |
No ancestor or descendant has a Class I recall.
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/P850079 · printed Nov 6, 2026
Cite this page
510(k) Report. “P850079: Hydrasoft (Methafilcon B) Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850079
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026