PMA P980040S178

Device: TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375;
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S178
Product code: HQL
Decision date: 2025-10-24
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: the implementation of a revised sampling process for torque testing of the pre-loaded Simplicity and SmartLoad delivery systems at the JJSV-AMO manufacturing facility in Groningen, The Netherlands

Current openFDA PMA Record#

Device: TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375;
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S178
Product code: HQL
Generic name: intraocular lens
Decision date: 2025-10-24
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the implementation of a revised sampling process for torque testing of the pre-loaded Simplicity and SmartLoad delivery systems at the JJSV-AMO manufacturing facility in Groningen, The Netherlands