PMA P980040

Device
TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S154
Product code
MJP
Decision date
2026-05-19
Generic name
LENS, INTRAOCULAR, TORIC OPTICS
Approval order statement
approval for TECNIS Eyhance™ Toric II one-piece IOLs in the SmartLOAD™ Delivery Technology packaging configuration.

Current openFDA PMA Record#

Device
TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S182
Product code
MJP
Generic name
LENS, INTRAOCULAR, TORIC OPTICS
Decision date
2026-05-19
Decision code
APPR
Date received
2026-02-27
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
approval for TECNIS Eyhance™ Toric II one-piece IOLs in the SmartLOAD™ Delivery Technology packaging configuration.