PMA P890047

Device: PROVISC™ Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S059
Product code: LZP
Decision date: 2026-10-01
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: a change in the Endotoxin testing program for the subject ophthalmic viscosurgical devices (OVDs), including test article preparation and individual component testing

Current openFDA PMA Record#

Device: PROVISC™ Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S072
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2026-10-01
Decision code: OK30
Date received: 2026-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the Endotoxin testing program for the subject ophthalmic viscosurgical devices (OVDs), including test article preparation and individual component testing