PMA P200020S011

Device
ClearView 3 IOL
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S011
Product code
MFK
Decision date
2026-03-25
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
approval for an extension of the power range from +15.0 through +30.0D to +10.0 through +36.0D for the ClearView 3 intraocular lenses (IOLs)

Current openFDA PMA Record#

Device
ClearView 3 IOL
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S011
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2026-03-25
Decision code
APPR
Date received
2026-01-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for an extension of the power range from +15.0 through +30.0D to +10.0 through +36.0D for the ClearView 3 intraocular lenses (IOLs)