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VOLK OPTICAL INC.

Last updated September 17, 2026

Information

Page 7 of 7

Device	Model / Reference	Registries	Class	Status
20D Large Clear, Blue Ring	V20LC-BE	FDA UDI	Class I	Active
Capsulotomy (VECAPS)	VECAPS	FDA UDI	Class II	Active
G-4 Mirror NF Large Ring	VG4LNF	FDA UDI	Class I	Active
Slt	VSLT	FDA UDI	Class I	Active
30D Small Clear	V30SC	FDA UDI	Class I	Active
G-6 NF 2in1 Handle	VG6HAN2	FDA UDI	Class I	Active
Rapid SLT	VLUMSLT	FDA UDI	Class I	Active
G-2 Trabeculum Flange	VG2	FDA UDI	Class I	Active
20D Large Clear, Custom Color Ring	V20LC-CC	FDA UDI	Class I	Active
HRX SSV Vit (VHRXVITSSV)	VHRXVITSSV	FDA UDI	Class II	Active
20D Large Clear, Silver Ring	V20LC-SR	FDA UDI	Class I	Active
30D Large Clear	V30LC	FDA UDI	Class I	Active
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens	K151961	FDA 510(k)	Class II	Active
Volk Disposable Vitrectomy Lenses, Models Volk Flat Ssv D, Volk Afx Ssv D, Volk 45 Prism Ssv D	K050623	FDA 510(k)	Class II	Active
Quadraspheric Fundus Lens	K943125	FDA 510(k)	Class II	Active
Contact Laser & Diagnostic Lenses	K023221	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 2, 2016	Z-1177-2016	—	terminated	The firm discovered that the incorrect lot number was engraved on the product.
Feb 27, 2015	Z-1685-2015	—	terminated	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Feb 27, 2015	Z-2055-2015	—	terminated	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Oct 25, 2012	Z-0966-2013	—	terminated	The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).
Jan 23, 2009	Z-1673-2009	—	terminated	Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.
Jun 30, 2008	Z-1710-2009	—	terminated	The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'