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PMA P840064S082

Device
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S082
Product code
LZP
Decision date
2023-08-31
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Addition of a sterility isolator in Lifecore Biomedical for performance of in-process and finished device testing of sterility for the subject 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
S082
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2023-08-31
Decision code
OK30
Date received
2023-08-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a sterility isolator in Lifecore Biomedical for performance of in-process and finished device testing of sterility for the subject devices.