PMA P200020S012
- Device
- Clearview 3
- Applicant
- Lenstec, Inc.
- PMA number
- P200020
- Supplement
- S012
- Product code
- MFK
- Decision date
- 2026-04-15
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- the addition of a new moist heat (steam) sterilizer, and associated increased maximum sterilization load size, for routine terminal sterilization of the subject intraocular lens devices
Current openFDA PMA Record#
- Device
- Clearview 3
- Applicant
- Lenstec, Inc.
- PMA number
- P200020
- Supplement
- S012
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2026-04-15
- Decision code
- OK30
- Date received
- 2026-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new moist heat (steam) sterilizer, and associated increased maximum sterilization load size, for routine terminal sterilization of the subject intraocular lens devices