# K081681: Vitrectomy Cutter and Accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Medical Optics, Inc.
- Decided: Oct 8, 2008 after 113 days
- Product code: MLZ (Vitrectomy, Instrument Cutter)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950287 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950287: Univit Probe, Medical Instrument Development Laboratories, Inc. (1995) Summary page 1.

## Recalls of this device
- Sep 24, 2018 · Class II · Z-1893-2019: 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, includ
- Mar 30, 2017 · Class II · Z-2096-2017: Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

## Indications for use
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.

Source page: https://510kreport.com/device/K081681
Methodology: https://510kreport.com/methodology