PMA P930014S012

Device: ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S012
Product code: HQL
Decision date: 2003-09-02
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY. THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."

Current openFDA PMA Record#

Device: ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S012
Product code: HQL
Generic name: intraocular lens
Decision date: 2003-09-02
Decision code: APPR
Date received: 2003-08-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY. THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."