PMA P980040S145

Device
TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs,
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S145
Product code
HQL
Decision date
2022-02-17
Generic name
intraocular lens
Approval order statement
Update the tolerance ranges of the Haptic Blocker/ Haptic Cup that are manufacturing processing aids for applicable toric intraocular lenses.

Current openFDA PMA Record#

Device
TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs,
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S145
Product code
HQL
Generic name
intraocular lens
Decision date
2022-02-17
Decision code
OK30
Date received
2022-01-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the tolerance ranges of the Haptic Blocker/ Haptic Cup that are manufacturing processing aids for applicable toric intraocular lenses.