510(k) · Cleared
Recalled · Class II · 2018Vitrectomy Cutter and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Optics, Inc. · MLZ Vitrectomy, Instrument Cutter
Cleared on Oct 8, 2008 as substantially equivalent to K950287 (Medical Instrument Development Laboratories, Inc., 1995) after a 113-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 2 times.
- Decided
- Oct 8, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- MLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950287 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950287 Univit ProbeMedical Instrument Development Laboratories, Inc. · 1995
- This deviceK081681 Vitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950287 | Univit Probe | Medical Instrument Development Laboratories, Inc. | 1995 | — |
| 0 (this device) | K081681 | Vitrectomy Cutter and Accessories | Advanced Medical Optics, Inc. | 2008 | — |
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 MLZ? 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 MLZ device
- #1 K220030 Vista Ophthalmics Vitrectomy Probescore 5.7 · 9 generations · no Class I recall
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 |
|---|---|---|---|
| * | K950287 | Univit ProbeSummary page 1…Irrigation Sleeve Classification: Class II, Tier II The devices to which substantial equivalence is claimed: K950287 March 3,1995 UnuVit and 4422CE… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2018 | Class II | Z-1893-2019 | Packaging process control | Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement. |
| Mar 30, 2017 | Class II | Z-2096-2017 | Packaging process control | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MLZ devicesMLZ Vitrectomy, Instrument Cutter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MLZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MLZ
Too few MLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MLZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLZ
251in 2025
MAUDE reports naming product code MLZ, 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 | 0 | — | 0 | 15 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 54 |
| 2021 | 0 | — | 0 | 40 |
| 2022 | 1 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 92 |
| 2024 | 0 | — | 0 | 186 |
| 2025 | 0 | — | 1 | 251 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure, These devices are for use with the Whitestar SignatureTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081681: Vitrectomy Cutter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081681
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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