PMA P840064S084

Device: VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S084
Product code: LZP
Decision date: 2024-03-27
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: adding an alternate sourcing of five excipients from Alcon’s approved suppliers for the production of OVDs at the Lifecore Biomedical manufacturing site

Current openFDA PMA Record#

Device: VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S084
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2024-03-27
Decision code: OK30
Date received: 2024-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an alternate sourcing of five excipients from Alcon’s approved suppliers for the production of OVDs at the Lifecore Biomedical manufacturing site