PMA P890047

Device: PROVISC Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S059
Product code: LZP
Decision date: 2026-08-04
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: PROVISC Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S070
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.