PMA P810031S081

Device: Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S081
Product code: LZP
Decision date: 2025-12-16
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: the addition of an alternative supplier of the holder assembly used to deliver the subject ophthalmic viscosurgical devices during surgery

Current openFDA PMA Record#

Device: Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S081
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2025-12-16
Decision code: OK30
Date received: 2025-11-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of an alternative supplier of the holder assembly used to deliver the subject ophthalmic viscosurgical devices during surgery