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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

DateFirmReason
2025-08-05Alcon Research LLCDue to incomplete seals in the pouch which provide the sterile barrier.
2025-04-28Alcon Research LLCDue 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
2018-09-24Johnson & Johnson Surgical Vision IncPackaging 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
2017-03-30Abbott 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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Data 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.