PMA P980040S155

Device: TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S155
Product code: HQL
Decision date: 2022-12-12
Generic name: intraocular lens
Approval order statement: Adding an alternate manufacturing and sterilization site at AMO Groningen B.V., Van Swietenlaan 5, Groningen, The Netherlands 9728NX for TECNISEyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, and TECNIS Eyhance Toric II IOLs with TECNIS Simplicity Delivery System, Models DIU150-600.

Current openFDA PMA Record#

Device: TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S155
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-12-12
Decision code: OK30
Date received: 2022-11-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adding an alternate manufacturing and sterilization site at AMO Groningen B.V., Van Swietenlaan 5, Groningen, The Netherlands 9728NX for TECNISEyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, and TECNIS Eyhance Toric II IOLs with TECNIS Simplicity Delivery System, Models DIU150-600.