VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.
FDA premarket approval P840064/S092 · decided 2026-08-04
Approval details
- PMA number
- P840064
- Supplement
- S092
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Laboratories
- Date received
- 2026-02-27
- Decision date
- 2026-08-04
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- An alternate manufacturing site at Alcon Fort Worth Manufacturing located at 6201 South Freeway, Fort Worth, Texas to perform the semiautomatic assembly of filled OVD (PROVISC, VISCOAT, and DUOVISC) syringes and components into blister packs, and packaging.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148) | Alcon Laboratories | 2000-04-11 |
| OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573) | Alcon Laboratories | 1999-09-16 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480) | Alcon Laboratories | 1999-05-10 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575) | Alcon Laboratories | 1999-01-14 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |