PMA P100016S003
- Device
- Aaris intraocular lens model EC-3 and EC-3 PAL
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S003
- Product code
- HQL
- Decision date
- 2017-04-18
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Approval for a new cosmetic inspection requirement to detect and reject intraocular lenses with Flat Optic Aberration.
Current openFDA PMA Record#
- Device
- Aaris intraocular lens model EC-3 and EC-3 PAL
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S003
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-04-18
- Decision code
- APPR
- Date received
- 2017-03-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new cosmetic inspection requirement to detect and reject intraocular lenses with Flat Optic Aberration.