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Alcon
Alcon Laboratories, Inc. · Model 8065752185 · UDI-DI 00380657521852
HQC
Prescription
10
510(k) clearances
41,091
Adverse events (6 deaths)
74
Recalls
74
Facilities
Description
ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° KELMAN* ABS* Tip
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.