PMA P980040S046

Device: TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S046
Product code: HQL
Decision date: 2014-04-28
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE INTRAOCULAR LENS IS INTENDED TO BE PLACED IN THECAPSULAR BAG.

Current openFDA PMA Record#

Device: TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S046
Product code: HQL
Generic name: intraocular lens
Decision date: 2014-04-28
Decision code: APPR
Date received: 2013-10-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE INTRAOCULAR LENS IS INTENDED TO BE PLACED IN THECAPSULAR BAG.