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Sign in to claim this brandVOLK OPTICAL INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 7893 ENTERPRISE DR., Mentor, OH, 44060
- Website
- volk.com
- —
- —
- [email protected]
- Phone
- 440-942-6161
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000122772
- DUNS Number
- 071125835
Catalogue (316)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Merlin CLA, Manual, 175 mm | 11377 | FDA UDI | Class I | Active |
| Mini Quad SSV (VMQVITSSV) | VMQVITSSV | FDA UDI | Class II | Active |
| Merlin CLA, Auto, 175 mm | 11375 | FDA UDI | Class I | Active |
| Merlin LPU for CLA, 175 mm | 11173 | FDA UDI | Class I | Active |
| Digital High Mag®, Red | VDGTLHM-RD | FDA UDI | Class I | Active |
| 60D Clear | V60C | FDA UDI | Class I | Active |
| Merlin CLA, Auto, 200 mm | 11376 | FDA UDI | Class I | Active |
| HR Direct Bi-Concave (VHRDBCACS) | VHRDBCACS | FDA UDI | Class II | Active |
| ROLS Reinverter - Leica+, Open Flange | VROLS-LX+ | FDA UDI | Class I | Active |
| Merlin Rotational Assembly (RA) | 11179 | FDA UDI | Class I | Active |
| 28D Large Clear, Silver Ring | V28LC-SR | FDA UDI | Class I | Active |
| Blumenthal Iridotomy (VBIRID) | VBIRID | FDA UDI | Class II | Active |
| Single Use 20D | V20LCD | FDA UDI | Class I | Active |
| 28D Large Clear ACS® PermaView | V28LCACSPV | FDA UDI | Class I | Active |
| Digital ClearMag | VDGTLCM | FDA UDI | Class I | Active |
| 15 Prism SSV ACS (VPRISMSSVACS) | VPRISMSSVACS | FDA UDI | Class II | Active |
| Digital Wide Field®, Purple | VDGTLWF-PE | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Clear, Purple Ring | VPRC-PE | FDA UDI | Class I | Active |
| Macula Plus® 5.5 | VMP5.5 | FDA UDI | Class I | Active |
| HR Direct 1X NSR Vit (VHRD1XNSRACS) | VHRD1XNSRACS | FDA UDI | Class II | Active |
| Merlin Mount, Topcon OMS90 | 11947 | FDA UDI | Class I | Active |
| Disposable Iridotomy (VIRIDD) | VIRIDD | FDA UDI | Class II | Active |
| Mounting Kit, Alcon Revalia | 12640 | FDA UDI | Class I | Active |
| 90D Clear, Red Ring | V90C-RD | FDA UDI | Class I | Active |
| Area Centralis (VAC) | VAC | FDA UDI | Class II | Active |
| Volk Pictor VP1RET | VP1RET | FDA UDI | Class II | Active |
| Merlin CLA, Manual, 200 mm | 11378 | FDA UDI | Class I | Active |
| HR Direct 1X Vit (VHRD1XACS) | VHRD1XACS | FDA UDI | Class II | Active |
| Digital 1.0X Mag | VDGTL1 | FDA UDI | Class I | Active |
| HR Centralis (VHRC) | VHRC | FDA UDI | Class II | Active |
| Volk SOLR Lens Arm | VSOLRLA | FDA UDI | Class I | Active |
| Vitreo Lens Handle for MQXL | VVITHAN-MQXL | FDA UDI | Class I | Active |
| Volk VistaView | VVISTAVIEW2 | FDA UDI | Class II | Active |
| ROLS Infinity, Leica - Manual | 11315 | FDA UDI | Class I | Active |
| Merlin Mount, Alcon | 11732 | FDA UDI | Class I | Active |
| Single Use 4-Mirror Gonio | V4MIRD | FDA UDI | Class I | Active |
| Merlin Mount, Leica | 11409 | FDA UDI | Class I | Active |
| Digital Wide Field®, Silver | VDGTLWF-SR | FDA UDI | Class I | Active |
| SuperField® NC, Green Ring | VSFNC-GN | FDA UDI | Class I | Active |
| Silver 20D | VSLV20 | FDA UDI | Class I | Active |
| G-3 Goniofundus Mini NF | VG3MININF | FDA UDI | Class I | Active |
| 78D Clear, Green Ring | V78C-GN | FDA UDI | Class I | Active |
| 20D Large Clear | V20LC | FDA UDI | Class I | Active |
| Super 66® Limited Edition #2 | VS66-LE2 | FDA UDI | Class I | Active |
| Disposable Direct Image Flat (VFD) | VFD | FDA UDI | Class II | Active |
| 78D Clear, Blue Ring | V78C-BE | FDA UDI | Class I | Active |
| SuperField® NC, Silver Ring | VSFNC-SR | FDA UDI | Class I | Active |
| Mounting Kit, Takagi OM-19 | 12650 | FDA UDI | Class I | Active |
| Merlin Wide Angle NC Lens | 11183 | FDA UDI | Class I | Active |
| Digital ClearField, Black Ring | VDGTLCF-BK | FDA UDI | Class I | Active |
Related Companies
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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.' |