ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

FDA premarket approval P040020 · decided 2005-03-21

Approval details

PMA number

P040020

Trade name

ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Generic name

Lens, multifocal intraocular

Applicant

Alcon Research, Ltd.

Date received

2004-04-19

Decision date

2005-03-21

Days to decision

336 days

Decision code

APPR

Product code

MFK

Advisory committee

Ophthalmic

Expedited review

No

Location

Fort Worth, TX

Statement

APPROVAL FOR THE ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS MA60D3 AND SA60D3. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.

510(k) clearances by this applicant