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Instrument, Vitreous Aspiration And Cutting, Ac-Powered

FDA product code HQE · Class 2 · Ophthalmic

570
Registered devices
5,942
Adverse events
37
Recalls
149
510(k) clearances

Devices with this code

Alcon — Alcon Laboratories, Inc.Bausch + Lomb — Bausch & Lomb IncorporatedBausch + Lomb — Bausch & Lomb IncorporatedAlcon, Engauge — Alcon Laboratories, Inc.Alcon — Alcon Laboratories, Inc.Bausch + Lomb — Bausch & Lomb IncorporatedBi-Blade® — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.EVA NEXUS™ Combined 23G TDC Pack — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Alcon, Engauge — Alcon Laboratories, Inc.Intrepid, AutoSert — Alcon Laboratories, Inc.23G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Bausch + Lomb — Bausch & Lomb IncorporatedEVA NEXUSTM Custom Phaco Pack 2.4mm 30 (Straight) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NA — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.UNITY — Alcon Laboratories, Inc.NA — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.23GA Soft Tip Aspirating Laser Probe - Alcon — Peregrine Surgical, LlcDisposable EVA Drapes — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Bausch + Lomb — Bausch & Lomb IncorporatedBausch + Lomb — Bausch & Lomb IncorporatedEVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Disposable EVA Air Fluid Dual Tubing — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.CONSTELLATION — Alcon Laboratories, Inc.Safety filter for Leica Microscopes, Passive — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Recent 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.