FDA.reportPublic FDA data

PMA P840064S069

Device
VISCOAT/DUOVISC Ophthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S069
Product code
LZP
Decision date
2018-06-28
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Use of an alternate additional large scale manufacturing process to manufacture VISCOAT® and VISCOAT® as part of DUOVISC® at the Alcon-Couvreur Manufacturing Site.

Current openFDA PMA Record#

Device
VISCOAT/DUOVISC Ophthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S069
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2018-06-28
Decision code
OK30
Date received
2018-06-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an alternate additional large scale manufacturing process to manufacture VISCOAT® and VISCOAT® as part of DUOVISC® at the Alcon-Couvreur Manufacturing Site.