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PMA P840064S081

Device
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S081
Product code
LZP
Decision date
2023-09-05
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Installation of a new cooler within Lifecore Biomedical’s site #3 warehouse for storage of work-in process materials and final product of the VISCOAT, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices.

Current openFDA PMA Record#

Device
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S081
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2023-09-05
Decision code
OK30
Date received
2023-08-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Installation of a new cooler within Lifecore Biomedical’s site #3 warehouse for storage of work-in process materials and final product of the VISCOAT, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices.