510(k) · Cleared
Recalled · 2004Foam Tip Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staar Surgical Co. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Sep 11, 1998 after a 200-day review. The FDA summary names its predicate without a number. 16 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 1998
- Review
- 200 days
- Class
- Class I
- Product code
- MSS
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK980696 Foam Tip InjectorStaar Surgical Co. · 1998
- Descendant · cites it directly · 12 of its ownK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- Descendant · 2 generations on · 10 of its ownK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- Descendant · 3 generations on · 7 of its ownK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · 4 generations on · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc. · 2005 · cites it directly12descendants
- K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006 · cites it directly11descendants
- K063802Lenstec LC Injection SystemLenstec, Inc. · 2007 · 2 generations on10descendants
- K103495Asico Softip Injector SystemAsico, LLC · 2011 · 3 generations on7descendants
- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980696 | Foam Tip Injector | Staar Surgical Co. | 1998 | — |
| +1 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| +1 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| +2 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| +3 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +4 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | — | MicroSTAAR™ Injector System (reusable and disposable) Named without a submission number |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2004 | Not classified | Z-0957-04 | Other | Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050638 (Lenstec, Inc., 2005) has gone furthest, with 12 descendants of its own.
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.
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 Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
There are no marketing claims for this device at this time.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980696: Foam Tip Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980696
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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