510(k) · Cleared
ClearedLenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lenstec, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on May 31, 2005 as substantially equivalent to K040837 (Medicel AG, 2004) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 1994. 12 later devices descend from it.
- Decided
- May 31, 2005
- Review
- 81 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930320 (1994). 6 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 2 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 1 generation backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- This deviceK050638 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 · cites it directly · 10 of its ownK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- Descendant · 2 generations on · 7 of its ownK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · 3 generations on · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006 · cites it directly11descendants
- K063802Lenstec LC Injection SystemLenstec, Inc. · 2007 · cites it directly10descendants
- K103495Asico Softip Injector SystemAsico, LLC · 2011 · 2 generations on7descendants
- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · 3 generations on6descendants
- K172228pioli IOL Delivery SystemAst Products, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −2 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −1 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| +2 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +3 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| +4 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K040837 | Multiject Injector and Microglide CartridgeSummary page 2…0000161 3. Substantially Equivalent legally-marketed devices: a. Medicel MultiJect Injector for IOLs and MicroGlide Cartridge K040837, June 17, 2004. b. STAAR Surgical Foam Tip T M Injector System K980696, Sept 11,1998. 4. Device Description:… | 2004 |
| * | K980696 | Foam Tip InjectorSummary page 2…ted devices: a. Medicel MultiJect Injector for IOLs and MicroGlide Cartridge K040837, June 17, 2004. b. STAAR Surgical Foam Tip T M Injector System K980696, Sept 11,1998. 4. Device Description: The system consists of the following components:… | 1998 |
What descends from it? (12)
See all 122 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K060533 (Lenstec, Inc., 2006) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K040837.
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 Lenstec IOL Injection System if intended for use in implantation of the Lenstec TetraflexTM Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050638
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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