- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S078
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2022-09-15
- Decision code
- OK30
- Date received
- 2022-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the blister seal integrity test method for the testing of the OVD blister.