- Device
- Lenstec Softec HD Posterior Chamber Intraocular Lens
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S032
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-03-15
- Decision code
- OK30
- Date received
- 2017-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Include the Lenstec manufacturing facility in Florida as the manufacturer of the lens polishing compound that is used during the manufacture of intraocular lenses.