PMA P980040S181

Device: SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S181
Product code: HQL
Decision date: 2026-01-12
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: the qualification of additional sterilization chambers, preconditioning and aeration rooms, and 2x (double) terminal sterilization approaches

Current openFDA PMA Record#

Device: SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S181
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-01-12
Decision code: OK30
Date received: 2025-12-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the qualification of additional sterilization chambers, preconditioning and aeration rooms, and 2x (double) terminal sterilization approaches