PMA · Approved
ApprovedBiornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Cooper Companies · LPM Lenses, Soft Contact, Extended Wear
Approved on Dec 11, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 69-day review.
- Decided
- Dec 11, 2025
- Review
- 69 days
- Class
- Class III
- Product code
- LPM
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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)
No FDA recall names this device.
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. 2025, this device’s year, is highlighted.
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/P890023/S056 · printed Nov 6, 2026
Cite this page
510(k) Report. “P890023/S056: Biornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P890023/S056
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026