PMA P840064S077

Device: VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S077
Product code: LZP
Decision date: 2022-09-13
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Change in the maximum Ethylene Oxide (EO) sterilization process parameter specifications (without change to the EO sterilization process set points or final product release specifications).

Current openFDA PMA Record#

Device: VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S077
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2022-09-13
Decision code: OK30
Date received: 2022-08-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the maximum Ethylene Oxide (EO) sterilization process parameter specifications (without change to the EO sterilization process set points or final product release specifications).