QCB — Phakic Toric Intraocular Lens Class III

FDA Device Classification

FDA product code QCB covers "Phakic Toric Intraocular Lens", a Class III medical device regulated under 21 CFR 886.3600. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants.

Classification Details

Product Code
QCB
Device Class
Class III
Regulation Number
886.3600
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Definition

Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.