- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S090
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-07-25
- Decision code
- OK30
- Date received
- 2025-07-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updating the Sodium Hyaluronate raw material testing by the supplier for the VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, DISCOVISC™ Ophthalmic Viscosurgical Device, and PROVISC™ Ophthalmic Viscosurgical Device