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Orbital sphere implant introducer

FCI S A S FCI 20 22 · Model SPHERE INTRODUCER · UDI-DI 03760087126389

HNP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.

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Data 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.