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PMA P040020S096

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S096
Product code
MFK
Decision date
2020-10-02
Generic name
Lens, multifocal intraocular
Approval order statement
Adding an alternate supplier for the blue tinted fiber strands which the Alcon Huntington (Alcon HWV) manufacturing site will further process into individual haptics for AcrySof® and AcrySof® ReSTOR® multi-piece intraocular lenses (IOLs).

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S096
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2020-10-02
Decision code
OK30
Date received
2020-09-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate supplier for the blue tinted fiber strands which the Alcon Huntington (Alcon HWV) manufacturing site will further process into individual haptics for AcrySof® and AcrySof® ReSTOR® multi-piece intraocular lenses (IOLs).