Lens, Multifocal Intraocular
Basic Information
- Device Name
- Lens, Multifocal Intraocular
- Trade Name
- ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS
- PMA Number
- P040020
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- MFK
- Generic Name
- Lens, multifocal intraocular
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 2009
- Date Received
- March 9, 2009
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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 PATIENTS WITH OR WITHOUTPRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MFK | Lens, Multifocal Intraocular | FDA class 3 | Ophthalmic |