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VOLK OPTICAL INC.

Last updated September 17, 2026

Information

Country: US
Address: 7893 ENTERPRISE DR., Mentor, OH, 44060
Website: volk.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 440-942-6161
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000122772
DUNS Number: 071125835

Catalogue (316)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
Disposable Capsulotomy (VCAPSD)	VCAPSD	FDA UDI	Class II	Active
Merlin Mount, Moleller Weidel	11410	FDA UDI	Class I	Active
28D Limited Edition	V28LC-LE	FDA UDI	Class I	Active
SuperField® NC	VSFNC	FDA UDI	Class I	Active
Volk SOLR Small Wide Angle Lens	VSOLRSWAL	FDA UDI	Class I	Active
ROLS Infinity, Zeiss - Manual	11313	FDA UDI	Class I	Active
iNview for iPod Touch (VINVIEW-TCH)	VINVIEW-TCH	FDA UDI	Class II	Active
Digital Wide Field®, Custom Color	VDGTLWF-CC	FDA UDI	Class I	Active
20D Limited Edition	V20LC-LE	FDA UDI	Class I	Active
Volk Vold Surgical Gonio Lens	VTSVVG	FDA UDI	Class I	Active
SuperField® NC, Red Ring	VSFNC-RD	FDA UDI	Class I	Active
Area Centralis (VEAC)	VEAC	FDA UDI	Class II	Active
Volk SOLR Condensing Lens 175	VSOLRCL175	FDA UDI	Class I	Active
20D Large Clear, Green Ring	V20LC-GN	FDA UDI	Class I	Active
Iridectomy (VEIRID)	VEIRID	FDA UDI	Class II	Active
HR Direct Prism Vit (VHRD20PACS)	VHRD20PACS	FDA UDI	Class II	Active
78D Clear, Red Ring	V78C-RD	FDA UDI	Class I	Active
HR Centralis (VEHRC)	VEHRC	FDA UDI	Class II	Active
Digital ClearField, Green Ring	VDGTLCF-GN	FDA UDI	Class I	Active
Super 66® Stereo Fundus	VS66	FDA UDI	Class I	Active
Merlin Mount, Spacer Kit	11425	FDA UDI	Class I	Active
28D Large Clear, Purple Ring	V28LC-PE	FDA UDI	Class I	Active
Disposable Direct Image Flat SSV (VFLATSSVD)	VFLATSSVD	FDA UDI	Class II	Active
SuperField® NC, Purple Ring	VSFNC-PE	FDA UDI	Class I	Active
G-6 Mirror NF Large Ring	VG6LNF	FDA UDI	Class I	Active
Mag Plus Iridectomy (VEMPIRID)	VEMPIRID	FDA UDI	Class II	Active
G-3 Goniofundus Flange	VG3	FDA UDI	Class I	Active
90D Clear, Green Ring	V90C-GN	FDA UDI	Class I	Active
Equator Plus NF (VEPNF)	VEPNF	FDA UDI	Class II	Active
Fundus 20mm (VFUNDUS20)	VFUNDUS20	FDA UDI	Class II	Active
iNview for iPhone 6 (VINVIEW-6)	VINVIEW-6	FDA UDI	Class II	Active
Digital High Mag®, Green	VDGTLHM-GN	FDA UDI	Class I	Active
Merlin Mount, L 820/840/841/844	12160	FDA UDI	Class I	Active
SuperField® NC, Gold Ring	VSFNC-GD	FDA UDI	Class I	Active
Super 66®, Purple Ring	VS66-PE	FDA UDI	Class I	Active
Merlin Mount, Topcon	11413	FDA UDI	Class I	Active
Mini 4 Mirror ANF+	V4MANF+	FDA UDI	Class I	Active
Volk SOLR Wide Angle Lens	VSOLRWAL	FDA UDI	Class I	Active
Singh MidVitreous (VSMV)	VSMV	FDA UDI	Class II	Active
Super 66®, Gold Ring	VS66-GD	FDA UDI	Class I	Active
Singh MidVitreous (VESMV)	VESMV	FDA UDI	Class II	Active
Rapid SLT	VMSLT	FDA UDI	Class I	Active
78D Clear, Silver Ring	V78C-SR	FDA UDI	Class I	Active
iNview Touch Camera (VINVIEWC-TCH)	VINVIEWC-TCH	FDA UDI	Class II	Active
Digital ClearField Limited Edition	VDGTLCF-LE	FDA UDI	Class I	Active
Volk Pictor VP1Handset, VP1RET	VP1RETK	FDA UDI	Class II	Active
20D Large Clear, Gold Ring	V20LC-GD	FDA UDI	Class I	Active
Digital High Mag®, Silver	VDGTLHM-SR	FDA UDI	Class I	Active
90D Clear, Custom Color Ring	V90C-CC	FDA UDI	Class I	Active
28D Limited Edition #2	V28LC-LE2	FDA UDI	Class I	Active

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FDA Recalls (6)

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.'