510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QCBClass III

Phakic Toric Intraocular Lens

21 CFR 886.3600 / Ophthalmic
FDA source (opens on fda.gov)

QCB is the FDA product code for Phakic Toric Intraocular Lens, a class III device type, regulated under 21 CFR 886.3600. FDA's definition for this code reads: "Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens". As of , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
QCB
Device name
Phakic Toric Intraocular Lens
FDA definition
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Regulation
21 CFR 886.3600
Device class
Class III
Review panel
Ophthalmic
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code