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PMA P930014S133

Device
AcrySof Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S133
Product code
HQL
Decision date
2020-10-02
Generic name
intraocular lens
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 Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S133
Product code
HQL
Generic name
intraocular lens
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).