- Device
- SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S023
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2007-08-30
- Decision code
- OK30
- Date received
- 2007-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE CLEANING SOLVENT, LIQUI-NOX, FOR THE 3-PIECE SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) MANUFACTURED AT THE AMO FACILITY IN ANASCO, PUERTO RICO.