PMA P100016S015
- Device
- CT LUCIA Intraocular Lens (IOL)
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S015
- Product code
- HQL
- Decision date
- 2023-01-05
- Generic name
- intraocular lens
- Approval order statement
- Changing to an automated extraction system used in hydrophobic button production of CT Lucia 602, CT Lucia 202, and CT Lucia 611P intraocular lens.
Current openFDA PMA Record#
- Device
- CT LUCIA Intraocular Lens (IOL)
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S015
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2023-01-05
- Decision code
- OK30
- Date received
- 2022-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changing to an automated extraction system used in hydrophobic button production of CT Lucia 602, CT Lucia 202, and CT Lucia 611P intraocular lens.