PMA P840064S094

Device: VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System; DISCOVISC™ Ophthalmic Viscosurgical
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S094
Product code: LZP
Decision date: 2026-10-01
Classification: Ophthalmic
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: VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System; DISCOVISC™ Ophthalmic Viscosurgical
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S094
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