PMA P980040S041

Device: TECNIS ITEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S041
Product code: HQL
Decision date: 2013-08-21
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.

Current openFDA PMA Record#

Device: TECNIS ITEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S041
Product code: HQL
Generic name: intraocular lens
Decision date: 2013-08-21
Decision code: APPR
Date received: 2012-09-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.