510(k) · Cleared
ClearedChiroflex II Lens Microsert (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Ophthalmics · HQL Intraocular Lens
Cleared on Jan 27, 1992 after a 123-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jan 27, 1992
- Review
- 123 days
- Class
- Class III
- Product code
- HQL
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
- Descendant · cites it directly · 17 of its ownK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
- Descendant · 2 generations on · 10 of its ownK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
- Descendant · 4 generations on · 3 of its ownK091507 Rayner Small Incision Single Use Soft Tipped Injector, Model…Rayner Intraocular Lenses, Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K970727Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · cites it directly17descendants
- K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006 · 2 generations on10descendants
- K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006 · 3 generations on5descendants
- K091507Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18Rayner Intraocular Lenses, Ltd. · 2009 · 4 generations on3descendants
- K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914311 | Chiroflex II Lens Microsert (TM) | Chiron Ophthalmics | 1992 | — |
| +1 | K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | 1997 | 1 |
| +2 | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | Rayner Surgical, Inc. | 2006 | — |
| +3 | K062612 | Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 | Rayner Surgical, Inc. | 2006 | — |
| +4 | K091507 | Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18 | Rayner Intraocular Lenses, Ltd. | 2009 | — |
| +2 | K090161 | Epiphany Injection System | Staar Surgical Co. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQL? 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970727 | Mport Foldable Lens Placement System | 1997 | 17 |
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, K970727 (Chiron Vision Corp., 1997) has gone furthest, with 17 descendants of its own.
How does its category compare?
All HQL devicesHQL Intraocular Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQL
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQL
Too few HQL 510(k)s in any year since 2007 to give a median.
Recalls per year · HQL
3in 2018
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HQL
3,792in 2025
MAUDE reports naming product code HQL, 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 | 51 | — | 0 | 3,640 |
| 2008 | 48 | — | 1 | 3,137 |
| 2009 | 33 | — | 2 | 1,868 |
| 2010 | 44 | — | 0 | 2,172 |
| 2011 | 32 | — | 9 | 2,672 |
| 2012 | 38 | — | 1 | 2,802 |
| 2013 | 30 | — | 1 | 2,555 |
| 2014 | 18 | — | 0 | 2,649 |
| 2015 | 27 | — | 2 (1) | 4,673 |
| 2016 | 48 | — | 0 | 2,214 |
| 2017 | 41 | — | 0 | 2,386 |
| 2018 | 39 | — | 3 | 2,501 |
| 2019 | 57 | — | 0 | 3,086 |
| 2020 | 49 | — | 0 | 1,981 |
| 2021 | 53 | — | 0 | 2,925 |
| 2022 | 34 | — | 0 | 3,290 |
| 2023 | 29 | — | 0 | 3,906 |
| 2024 | 35 | — | 0 | 3,110 |
| 2025 | 42 | — | 0 | 3,792 |
| 2026 | 38 | — | 0 | — |
https://510kreport.com/device/K914311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914311: Chiroflex II Lens Microsert (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914311
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026