Product code QCB

Device name

Phakic Toric Intraocular Lens

Medical specialty

Ophthalmic

Device class

3

Regulation number

886.3600

Review panel

OP

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset