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Constellation, Ultravit, TotalPlus, Engauge

Alcon Laboratories, Inc. · Model 8065751070 · UDI-DI 00380657510702

HQEHQC Prescription
10
510(k) clearances
5,964
Adverse events (2 deaths)
37
Recalls
38
Facilities

Description

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 20 GA TotalPlus Combined Procedure Pak Engauge RFID 1.1 mm Tipless Anterior Kit

Recalls

DateFirmReason
2026-04-30D.O.R.C. Dutch Opthalmic Research Center Intl B.V.An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
2026-04-30D.O.R.C. Dutch Opthalmic Research Center Intl B.V.An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
2026-04-30D.O.R.C. Dutch Opthalmic Research Center Intl B.V.An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
2025-08-05Alcon Research LLCDue to incomplete seals in the pouch which provide the sterile barrier.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.
2018-08-08Bausch & Lomb IncThe back cap separates from the body of the vitrectomy cutter.

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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.