PMA P060022S028
- Device
- Akreos One-Piece Foldable Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P060022
- Supplement
- S028
- Product code
- HQL
- Decision date
- 2020-12-21
- Generic name
- intraocular lens
- Approval order statement
- Transfer of the bioburden and endotoxin testing methods from Nelson Laboratories Inc. to in-house at the B+L Clearwater, FL facility.
Current openFDA PMA Record#
- Device
- Akreos One-Piece Foldable Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P060022
- Supplement
- S028
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-12-21
- Decision code
- OK30
- Date received
- 2020-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the bioburden and endotoxin testing methods from Nelson Laboratories Inc. to in-house at the B+L Clearwater, FL facility.