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UNITY
Alcon Laboratories, Inc. · Model 00380650003232 · UDI-DI 00380650003232
HQC
Prescription
10
510(k) clearances
40,951
Adverse events (6 deaths)
74
Recalls
74
Facilities
Description
UNITY Cataract FMS Pack, Tipless with Nano Infusion Sleeves
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Alcon Research LLC | Due to incomplete seals in the pouch which provide the sterile barrier. |
| 2025-04-28 | Alcon Research LLC | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| 2024-07-15 | Alcon Research LLC | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.