PMA P980040S110

Device: SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S110
Product code: HQL
Decision date: 2019-11-22
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Consolidation of the cosmetic inspection for the one-piece intraocular lenses packaged in the SmartLOAD Delivery Technology and TECNIS Simplicity Delivery System manufactured at the AMO Puerto Rico facility.

Current openFDA PMA Record#

Device: SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S110
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-11-22
Decision code: OK30
Date received: 2019-11-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Consolidation of the cosmetic inspection for the one-piece intraocular lenses packaged in the SmartLOAD Delivery Technology and TECNIS Simplicity Delivery System manufactured at the AMO Puerto Rico facility.