PMA P990080S055

Device
TECNIS Foldable Acrylic IOL
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P990080
Supplement
S055
Product code
HQL
Decision date
2021-01-08
Generic name
intraocular lens
Approval order statement
Alternate ethylene oxide sterilization cycle parameters.

Current openFDA PMA Record#

Device
TECNIS Foldable Acrylic IOL
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P990080
Supplement
S055
Product code
HQL
Generic name
intraocular lens
Decision date
2021-01-08
Decision code
OK30
Date received
2020-12-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate ethylene oxide sterilization cycle parameters.