PMA P910061S025
- Device
- SofPort Posterior Chamber Intraocular Lenses
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S025
- Product code
- HQL
- Decision date
- 2019-02-28
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and PMMA intraocular lenses be transferred to a new testing laboratory.
Current openFDA PMA Record#
- Device
- SofPort Posterior Chamber Intraocular Lenses
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S025
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-02-28
- Decision code
- OK30
- Date received
- 2019-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and PMMA intraocular lenses be transferred to a new testing laboratory.