- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S085
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2024-06-17
- Decision code
- OK30
- Date received
- 2024-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to use a campaign filling strategy for the production of PROVISC™ Ophthalmic Viscosurgical Device, VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs at the Lifecore Biomedical manufacturing site