Volk Optical Inc
Mentor, OH, US
VOLK OPTICAL INC. appears in FDA device records in Mentor, OH. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Volk Optical Inc between 1994 and 2015. The busiest year on record is 1994, with 1. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | HJK | Substantially Equivalent | |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | HJK | Substantially Equivalent | |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | HJK | Substantially Equivalent | |
| K943125 | QUADRASPHERIC FUNDUS LENS | HJK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1528142 | 1000122772 | VOLK OPTICAL INC. | 7893 ENTERPRISE DR., Mentor, OH 44060 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HKICamera, Ophthalmic, Ac-Powered
- PJZCamera, Ophthalmic, General-Use
- KYGDevice, Irrigation, Ocular Surgery
- HNRForceps, Ophthalmic
- HJLLens, Condensing, Diagnostic
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic
- KYTLight, Examination, Medical, Battery Powered
- OUGMedical Device Data System
- FSOMicroscope, Surgical, General & Plastic Surgery
- HLJOphthalmoscope, Battery-Powered
- ERAOtoscope
- HKSPrism, Gonioscopic
- HNHRing, Ophthalmic (Flieringa)
- HMGStand, Instrument, Ophthalmic, Non-Powered
- LLZSystem, Image Processing, Radiological
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1177-2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities | The firm discovered that the incorrect lot number was engraved on the product. | Class III | Terminated | |
| Z-2055-2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. | 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. | Class III | Terminated | |
| Z-1685-2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. | Class III | Terminated | |
| Z-0966-2013 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. | 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). | Class III | Terminated | |
| Z-1673-2009 | Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures. | 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. | Terminated | ||
| Z-1710-2009 | G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy. | 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.' | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain