PMA P990080S056

Device
TECNIS® Foldable Acrylic IOL
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P990080
Supplement
S056
Product code
HQL
Decision date
2022-12-06
Generic name
intraocular lens
Approval order statement
Adding an alternative supplier for the lens case assembly (LCA).

Current openFDA PMA Record#

Device
TECNIS® Foldable Acrylic IOL
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P990080
Supplement
S056
Product code
HQL
Generic name
intraocular lens
Decision date
2022-12-06
Decision code
OK30
Date received
2022-11-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternative supplier for the lens case assembly (LCA).