- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S086
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2024-08-12
- Decision code
- OK30
- Date received
- 2024-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- moving the particulate testing for PROVISC™ Ophthalmic Viscosurgical Device (OVD), VISCOAT™ OVD, DUOVISC™ OVD, and DISCOVISC™ OVD