ACRYSOF RESTOR IQ IOL

FDA premarket approval P040020/S010 · decided 2008-06-20

Approval details

PMA number

P040020

Supplement

S010

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

ACRYSOF RESTOR IQ IOL

Generic name

Lens, multifocal intraocular

Applicant

Alcon Research, Ltd.

Date received

2008-04-15

Decision date

2008-06-20

Days to decision

66 days

Decision code

APPR

Product code

MFK

Advisory committee

Ophthalmic

Expedited review

No

Location

Fort Worth, TX

Statement

APPROVAL FOR CHANGING THE TRADE NAME OF THE DEVICE FROM ACRYSOF RESTOR ASPHERIC APODIZED DIFFRACTIVE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) TO ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL, MODEL SN6AD3, AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND

510(k) clearances by this applicant