PMA P200020S009

Device
ClearView 3 Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S009
Product code
MFK
Decision date
2025-08-12
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
A new milling machine for Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM, and ClearView 3 lenses

Current openFDA PMA Record#

Device
ClearView 3 Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S009
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2025-08-12
Decision code
OK30
Date received
2025-07-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
A new milling machine for Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM, and ClearView 3 lenses