PMA P840064S088

Device
DISCOVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S088
Product code
LZP
Decision date
2025-02-26
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
adding two mixing vessels for the manufacturing of PROVISC™ Ophthalmic Viscosurgical Device and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs

Current openFDA PMA Record#

Device
DISCOVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S088
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2025-02-26
Decision code
OK30
Date received
2025-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
adding two mixing vessels for the manufacturing of PROVISC™ Ophthalmic Viscosurgical Device and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs