PMA P840064S092

Device: VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S092
Product code: LZP
Decision date: 2026-08-04
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: An alternate manufacturing site at Alcon Fort Worth Manufacturing located at 6201 South Freeway, Fort Worth, Texas to perform the semiautomatic assembly of filled OVD (PROVISC, VISCOAT, and DUOVISC) syringes and components into blister packs, and packaging.

Current openFDA PMA Record#

Device: VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S092
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2026-08-04
Decision code: APPR
Date received: 2026-02-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: An alternate manufacturing site at Alcon Fort Worth Manufacturing located at 6201 South Freeway, Fort Worth, Texas to perform the semiautomatic assembly of filled OVD (PROVISC, VISCOAT, and DUOVISC) syringes and components into blister packs, and packaging.