Home › Carl Zeiss Meditec AG › SLEEVE,TEST CHAMBER SET PLUS 21G
SLEEVE,TEST CHAMBER SET PLUS 21G
Carl Zeiss Meditec AG · Model 303060-1031-000 · UDI-DI 04049539102560
HQC
Prescription
1
510(k) clearances
41,091
Adverse events (6 deaths)
74
Recalls
74
Facilities
Description
This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER and SILICONE SLEEVE).
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.