ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

FDA premarket approval P040020/S014 · decided 2009-08-20

Approval details

PMA number

P040020

Supplement

S014

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

Generic name

Lens, multifocal intraocular

Applicant

Alcon Research, Ltd.

Date received

2009-03-09

Decision date

2009-08-20

Days to decision

164 days

Decision code

APPR

Product code

MFK

Advisory committee

Ophthalmic

Expedited review

No

Location

Fort Worth, TX

Statement

APPROVAL FOR CHANGES TO THE LABELING,REVISING THE DIRECTIONS FOR USE (DFU) AND PATIENT BROCHURE WITH UPDATED SIX-MONTHFOLLOW UP DATA FROM THE CLINICAL INVESTIGATION FOR THE LENSES. THE DEVICES, AS MODIFIEDWILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR INTRAOCULAR LENSES(IOLS) +3.0 D (MODELS: SN6AD1 AND MN6AD1) AND +4.0 D (MODELS: SN6AD3 ANDMN6AD3) ADD POWERS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTIONOF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT

510(k) clearances by this applicant