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GONIO ready® CL
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Model 10012719 · UDI-DI 04049584034212
HKS
Prescription
10
510(k) clearances
4
Adverse events
1
Recalls
19
Facilities
Description
The GONIO ready® CL (Contact Lens) is a self-stabilizing, single-use, direct gonioscopy lens used to enable bimanual surgery inMinimally Invasive Glaucoma Surgery (MIGS) procedures. Intended for direct visualization of the anterior chamber angle andretention atop the cornea without manual stabilization of the lens. Indicated for diagnostic use during minimally invasive glaucomasurgery. The device is primarily used in conjunction with a surgical operating microscope in hospitals, surgery centers, clinics, andother medical institutions.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-06-30 | Volk Optical Inc | 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.' |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.