PMA P840064S091

Device
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S091
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
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S091
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