PMA · Approved
Recalled · Class I · 2025enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · MFK Lens, Multifocal Intraocular
Approved on Oct 10, 2024 through premarket approval, which rests on the device’s own clinical evidence after a 216-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 10, 2024
- Review
- 216 days
- Class
- Class III
- Product code
- MFK
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P240005 has 10 supplements since 2024: 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 |
|---|---|
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 6 |
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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2025 | Class I | Z-1680-2025 | Process control | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MFK devicesMFK Lens, Multifocal Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MFK
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MFK
Too few MFK 510(k)s in any year since 2007 to give a median.
Recalls per year · MFK
No recall names MFK since 2007.
Adverse event reports per year · MFK
717in 2025
MAUDE reports naming product code MFK, 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 | 13 | — | 0 | 35 |
| 2008 | 12 | — | 0 | 420 |
| 2009 | 14 | — | 0 | 586 |
| 2010 | 9 | — | 0 | 601 |
| 2011 | 10 | — | 0 | 584 |
| 2012 | 9 | — | 0 | 308 |
| 2013 | 9 | — | 0 | 296 |
| 2014 | 5 | — | 0 | 308 |
| 2015 | 3 | — | 0 | 708 |
| 2016 | 11 | — | 0 | 731 |
| 2017 | 12 | — | 0 | 613 |
| 2018 | 12 | — | 0 | 629 |
| 2019 | 8 | — | 0 | 683 |
| 2020 | 4 | — | 0 | 912 |
| 2021 | 8 | — | 0 | 1,205 |
| 2022 | 8 | — | 0 | 1,265 |
| 2023 | 6 | — | 0 | 1,047 |
| 2024 | 11 | — | 0 | 859 |
| 2025 | 14 | — | 0 | 717 |
| 2026 | 17 | — | 0 | — |
https://510kreport.com/device/P240005 · printed Nov 6, 2026
Cite this page
510(k) Report. “P240005: enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P240005
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026