PMA P040020S094

Device
AcrySof ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
Product code
MFK
Decision date
2021-02-18
Generic name
Lens, multifocal intraocular
Approval order statement
Approval for a contract sterilization site located at Synergy Health Sterilisation UK Ltd., Unit 1, Alpha Court, Capitol Park, Thorne, Doncaster DN8 5TZ United Kingdom.

Current openFDA PMA Record#

Device
AcrySof ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S094
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2021-02-18
Decision code
APPR
Date received
2020-05-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a contract sterilization site located at Synergy Health Sterilisation UK Ltd., Unit 1, Alpha Court, Capitol Park, Thorne, Doncaster DN8 5TZ United Kingdom.