510(k) · Cleared
ClearedXact Lens Inserter System, Models 6MM, 7MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sis Ltd., Surgical Instrument Systems · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jul 9, 2009 as substantially equivalent to K983129 (Staar Surgical Co., 1998) and 2 other predicates after a 283-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jul 9, 2009
- Review
- 283 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K983129 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK983129 Disposable Microstaar Injector (Model Msi-P1)Staar Surgical Co. · 1998
- This deviceK082871 Xact Lens Inserter System, Models 6MM, 7MMSis Ltd., Surgical Instrument Systems · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983129 | Disposable Microstaar Injector (Model Msi-P1) | Staar Surgical Co. | 1998 | — |
| 0 (this device) | K082871 | Xact Lens Inserter System, Models 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983129 | Disposable Microstaar Injector (Model Msi-P1)Summary page 2…ks in place on the handpiece. Substantial Equivalence The predicate devices which we are claiming substantial equivalence to are: - Micro STAARTM Injector MSI-P1 (K983129) - the CeeOnTM EASYSERT (K002556) - the MONARCH ® II IOL (K003768) Performance data The xactTM lens inserter (Model 6… | 1998 |
| * | K002556 | Ceeon Easysert Intraocular Lens Injector, Model Imp-1Summary page 2…ntial Equivalence The predicate devices which we are claiming substantial equivalence to are: - Micro STAARTM Injector MSI-P1 (K983129) - the CeeOnTM EASYSERT (K002556) - the MONARCH ® II IOL (K003768) Performance data The xactTM lens inserter (Model 6mm / 7mm) has been tested in vitro for… | 2000 |
| * | K003768 | Monarch II Iol Delivery SystemSummary page 2…s which we are claiming substantial equivalence to are: - Micro STAARTM Injector MSI-P1 (K983129) - the CeeOnTM EASYSERT (K002556) - the MONARCH ® II IOL (K003768) Performance data The xactTM lens inserter (Model 6mm / 7mm) has been tested in vitro for proper functioning under various cond… | 2001 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K983129.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, 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 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The xact TM foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal small-incision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082871: Xact Lens Inserter System, Models 6MM, 7MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082871
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026