FDA product code MLZ: Vitrectomy, Instrument Cutter
MLZ is the FDA product code for vitrectomy, instrument cutter. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under MLZ, 1 in the last five years, from 3 different applicants. The average 510(k) review took 106 days (median 116). FDA has posted 4 recalls for MLZ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Vitrectomy, Instrument Cutter |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 28 |
| 2022 | 1 | 119 |
Compare with all 510(k) review times · Search every MLZ clearance
Top MLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alcon Research, Ltd. | 2 | 2017-03-22 |
| Vista Ophthalmics, LLC | 1 | 2022-05-04 |
| Advanced Medical Optics, Inc. | 1 | 2008-10-08 |
Most recent MLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220030 | Vista Ophthalmics, LLC | Vista Ophthalmics Vitrectomy Probe | 2022-05-04 | 119 |
| K170520 | Alcon Research, Ltd. | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | 2017-03-22 | 28 |
| K093305 | Alcon Research, Ltd. | ENHANCED ULTRA VIT PROBE | 2010-04-02 | 162 |
| K081681 | Advanced Medical Optics, Inc. | VITRECTOMY CUTTER AND ACCESSORIES | 2008-10-08 | 113 |
Recalls for MLZ devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code MLZ?
MLZ is the FDA product code for vitrectomy, instrument cutter. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is MLZ?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLZ?
Across 4 cleared submissions the average was 106 days from receipt to decision (median 116).
Which companies have the most MLZ clearances?
Alcon Research, Ltd. (2); Vista Ophthalmics, LLC (1); Advanced Medical Optics, Inc. (1).
Have MLZ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MLZ
- Run a recall and safety report across every MLZ manufacturer
- Watch product code MLZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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