Home › Alcon Laboratories, Inc. › Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT
Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT
Alcon Laboratories, Inc. · Model 8065752450 · UDI-DI 00380657524501
MLZ
Prescription
4
510(k) clearances
895
Adverse events
4
Recalls
24
Facilities
Description
25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator 0.9 mm Tipless Anterior Kit
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 |
| 2018-09-24 | Johnson & Johnson Surgical Vision Inc | Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgi |
| 2017-03-30 | Abbott Medical Optics Inc. (AMO) | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. |
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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.
