PMA P980040S179

Device: TECNIS SIMPLICITY™ Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S179
Product code: HQL
Decision date: 2025-12-16
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: an increase in the maximum aeration phase load size for degassing of TECNIS 1-Piece intraocular lenses (IOL) with TECNIS SIMPLICITY Delivery System sterilized by Ethylene Oxide at AMO Groningen

Current openFDA PMA Record#

Device: TECNIS SIMPLICITY™ Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S179
Product code: HQL
Generic name: intraocular lens
Decision date: 2025-12-16
Decision code: OK30
Date received: 2025-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an increase in the maximum aeration phase load size for degassing of TECNIS 1-Piece intraocular lenses (IOL) with TECNIS SIMPLICITY Delivery System sterilized by Ethylene Oxide at AMO Groningen