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Instrument, Vitreous Aspiration And Cutting, Ac-Powered

FDA product code HQE · Class 2 · Ophthalmic

570
Registered devices
5,984
Adverse events
37
Recalls
149
510(k) clearances

Devices with this code

Alcon — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.Synergetics — SYNERGETICS USA, INC.Bausch + Lomb — Bausch & Lomb IncorporatedAlcon, Engauge — Alcon Laboratories, Inc.EVA TDC Vitrectomy Pack Gravity Input 25G — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Synergetics — SYNERGETICS USA, INC.EVA NEXUS™ Irrigation and Aux. Aspiration Tubing — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Bi-Blade® — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.EVA NEXUS™ Digital Overlay System — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Disposable infusion sleeve for 2.2 mm phaco needle Including test chamber — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.EVA NEXUSTM Custom Phaco Pack 2.2mm 45 (Straight) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Synergetics — SYNERGETICS USA, INC.Infiniti — Alcon Laboratories, Inc.NA — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.CENTURION® INTREPID® — Alcon Laboratories, Inc.Synergetics — SYNERGETICS USA, INC.Bi-Blade® — MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.Synergetics — SYNERGETICS USA, INC.Alcon, Engauge — Alcon Laboratories, Inc.Accurus, Alcon — Alcon Laboratories, Inc.EVA NEXUSTM Custom Cartridge with 0.5 L collection bag — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Synergetics — SYNERGETICS USA, INC.Bausch + Lomb — Bausch & Lomb Incorporated

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.