FDA.reportPublic FDA data

PMA P840064S072

Device
VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S072
Product code
LZP
Decision date
2020-09-16
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Adding Lifecore as an additional release testing site for raw materials and primary packaging components used in the manufacturing process of VISCOAT, PROVISC and DUOVISC.

Current openFDA PMA Record#

Device
VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S072
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2020-09-16
Decision code
OK30
Date received
2020-08-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding Lifecore as an additional release testing site for raw materials and primary packaging components used in the manufacturing process of VISCOAT, PROVISC and DUOVISC.