PMA P980040S068

Device: TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S068
Product code: HQL
Decision date: 2016-05-13
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Addition of an alternate molding supplier for the lower and upper body components used in all TECNIS iTec Preloaded Delivery System lens models manufactured at the AMO Puerto Rico and AMO Groningen BV sites.

Current openFDA PMA Record#

Device: TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S068
Product code: HQL
Generic name: intraocular lens
Decision date: 2016-05-13
Decision code: OK30
Date received: 2016-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate molding supplier for the lower and upper body components used in all TECNIS iTec Preloaded Delivery System lens models manufactured at the AMO Puerto Rico and AMO Groningen BV sites.