ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

FDA premarket approval P040020/S005 · decided 2007-10-24

Approval details

PMA number

P040020

Supplement

S005

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Generic name

Lens, multifocal intraocular

Applicant

Alcon Research, Ltd.

Date received

2007-08-06

Decision date

2007-10-24

Days to decision

79 days

Decision code

APPR

Product code

MFK

Advisory committee

Ophthalmic

Expedited review

No

Location

Fort Worth, TX

Statement

APPROVAL FOR EXPANSION OF THE DIOPTRIC RANGE OF THE REFERENCED MODELS FROM 10.0D TO 30.0D TO 6.0D TO 30.0D. THE DEVICE MODELS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODELS SA60D3, SN60D3, MA60D3 AND MN60D3, AND ARE 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 W

510(k) clearances by this applicant