21 CFR § 886.3340 Ophthalmic Devices

§ 886.3340 Extraocular orbital implant.

Current through Sep 8, 2026 · Read all of Part 886

(a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

(b) Classification. Class II.

← § 886.3320 Eye sphere implant.§ 886.3400 Keratoprosthesis. →