Is this your brand? Sign in to claim ownership.
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 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mini Quad XL VIT SSV (VMQXLVITSSV) | VMQXLVITSSV | FDA UDI | Class II | Active |
| 20D Large Clear ACS® PermaView | V20LCACSPV | FDA UDI | Class I | Active |
| TransEquator (VTE) | VTE | FDA UDI | Class I | Active |
| Volk Infusion Handle | VINFHAN | FDA UDI | Class I | Active |
| Flat SSV ACS (VFLATSSVACS) | VFLATSSVACS | FDA UDI | Class II | Active |
| Merlin Mid-Field NC Lens | 11182 | FDA UDI | Class I | Active |
| HR Direct HM NSR Vit (VHRDHMNSRACS) | VHRDHMNSRACS | FDA UDI | Class II | Active |
| 28D Cielo | C28 | FDA UDI | Class I | Active |
| Volk Pictor Plus VP2HAND AND VP2RET | VP2RETK | FDA UDI | Class II | Active |
| Capsulotomy (VCAPS) | VCAPS | FDA UDI | Class II | Active |
| Volk SOLR Condensing Lens | VSOLRCL | FDA UDI | Class I | Active |
| Silver 78D | VSLV78 | FDA UDI | Class I | Active |
| Volk SOLR Surgical System 175 | VSOLR175 | FDA UDI | Class I | Active |
| Merlin RA Mount, Leica 690 | 11411 | FDA UDI | Class I | Active |
| G-4 HighMag Small Ring NF | VG4HMSNF | FDA UDI | Class I | Active |
| Merlin Mount, MW HS HiR | 12161 | FDA UDI | Class I | Active |
| Merlin Mount, Zeiss Visu | 12163 | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Clear, Blue Ring | VPRC-BE | FDA UDI | Class I | Active |
| Single Use 28D | V28LCD | FDA UDI | Class I | Active |
| Condenser Lens Replacement, 200 mm | 11277 | FDA UDI | Class I | Active |
| Volk VistaView | VVISTAVIEW | FDA UDI | Class II | Active |
| Surgical Goniotomy | VSGACS | FDA UDI | Class I | Active |
| ROLS Reinverter - Leica+ | VROLS-L+ | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Clear, Gold Ring | VPRC-GD | FDA UDI | Class I | Active |
| G-4 NF 2in1 Handle | VG4HAN2 | FDA UDI | Class I | Active |
| Mini Quad VIT (VMQVIT) | VMQVIT | FDA UDI | Class II | Active |
| SuperField® NC, Custom Color | VSFNC-CC | FDA UDI | Class I | Active |
| ROLS Reinverter - Leica, Open Flange | VROLS-LX | FDA UDI | Class I | Active |
| QuadrAspheric NF (VQFLNF) | VQFLNF | FDA UDI | Class II | Active |
| Digital High Mag® Limited Edition | VDGTLHM-LE | FDA UDI | Class I | Active |
| Super 66®, Silver Ring | VS66-SR | FDA UDI | Class I | Active |
| Equator Plus ANF+ (VEPANF+) | VEPANF+ | FDA UDI | Class II | Active |
| 90D Clear, Blue Ring | V90C-BE | FDA UDI | Class I | Active |
| TransEquator ANF+ (VTEANF+) | VTEANF+ | FDA UDI | Class II | Active |
| Mounting Kit, Takagi OM-9 | 12645 | FDA UDI | Class I | Active |
| Super Quad 160 (VSQUAD160) | VSQUAD160 | FDA UDI | Class II | Active |
| High Mag SSV ACS (VFHMSSVACS) | VFHMSSVACS | FDA UDI | Class II | Active |
| Super 66®, Blue Ring | VS66-BE | FDA UDI | Class I | Active |
| TransEquator NF (VTENF) | VTENF | FDA UDI | Class II | Active |
| 78D Clear, Custom Color Ring | V78C-CC | FDA UDI | Class I | Active |
| Area Centralis NF (VACNF) | VACNF | FDA UDI | Class II | Active |
| Volk Viva | VVIVA1B | FDA UDI | Class II | Active |
| MiniQuad ACS (VMQVITACS) | VMQVITACS | FDA UDI | Class II | Active |
| 3 Mirror No Flange | V3MIR | FDA UDI | Class I | Active |
| 78D Clear | V78C | FDA UDI | Class I | Active |
| Central Retinal Vit (VCRLVIT) | VCRLVIT | FDA UDI | Class II | Active |
| Super Quad 160 (VESQUAD160) | VESQUAD160 | FDA UDI | Class II | Active |
| Volk Pictor VP1Handset | VP1HAND | FDA UDI | Class II | Active |
| Idrees MidVitreous (VIMV) | VIMV | FDA UDI | Class II | Active |
| 25D Large Clear | V25LC | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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.' |