PMA P840064S089

Device: VISCOAT™ Ophthalmic Viscosurgical Device
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S089
Product code: LZP
Decision date: 2026-02-10
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: approval for adding a new fill volume (0.75 mL) of an ophthalmic viscosurgical device (OVD) into a 1 mL syringe. This would be produced at the LifeCore Biomedical site.

Current openFDA PMA Record#

Device: VISCOAT™ Ophthalmic Viscosurgical Device
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S089
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2026-02-10
Decision code: APPR
Date received: 2025-06-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for adding a new fill volume (0.75 mL) of an ophthalmic viscosurgical device (OVD) into a 1 mL syringe. This would be produced at the LifeCore Biomedical site.