PMA P190018S017
- Device
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S017
- Product code
- HQL
- Decision date
- 2021-12-28
- Generic name
- intraocular lens
- Approval order statement
- Modifications to the sampling plan for edge thickness.
Current openFDA PMA Record#
- Device
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S017
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-28
- Decision code
- OK30
- Date received
- 2021-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the sampling plan for edge thickness.