# K050623: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D

- Pathway: 510(k) (Special)
- Applicant: Volk Optical, Inc.
- Decided: Mar 28, 2005 after 18 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943125 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012096: Disposable Vitrectomy Lens, Ocular Instruments, Inc. (2001)
- K943125: Quadraspheric Fundus Lens, Volk Optical, Inc. (1994) Summary page 1.

## Most influential descendants
- K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (2015), 1 descendant of its own
- K173944: Endocular Viewing Lenses and Silicone Ring (2018), 0 descendants of its own

## Recalls of this device
- Dec 16, 2025 · Class II · Z-1244-2026: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to 

## Indications for use
The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapV of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

Source page: https://510kreport.com/device/K050623
Methodology: https://510kreport.com/methodology