PMA P810031S082

Device: Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S082
Product code: LZP
Decision date: 2026-07-28
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: to automate several steps on the manufacturing line of the Healon PRO family of products at the current manufacturing site AMO Uppsala AB (Uppsala, Sweden)

Current openFDA PMA Record#

Device: Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S082
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2026-07-28
Decision code: OK30
Date received: 2026-06-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to automate several steps on the manufacturing line of the Healon PRO family of products at the current manufacturing site AMO Uppsala AB (Uppsala, Sweden)