PMA P890047S069

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S069
Product code
LZP
Decision date
2025-10-03
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
updating the cannula incoming inspections procedures for the VISCOAT™ Ophthalmic Viscosurgical Device (OVD), DUOVISC™ Ophthalmic Viscoelastic System, DISCOVISC™ Ophthalmic Viscosurgical Device, and PROVISC™ Ophthalmic Viscosurgical Device

Current openFDA PMA Record#

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S069
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2025-10-03
Decision code
OK30
Date received
2025-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
updating the cannula incoming inspections procedures for the VISCOAT™ Ophthalmic Viscosurgical Device (OVD), DUOVISC™ Ophthalmic Viscoelastic System, DISCOVISC™ Ophthalmic Viscosurgical Device, and PROVISC™ Ophthalmic Viscosurgical Device