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Bi-Blade®

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. · Model 2340BB · UDI-DI 00812480010758

HQE Prescription
1
510(k) clearances
5,942
Adverse events (2 deaths)
37
Recalls
38
Facilities

Description

25 Gauge BB Vitreous Cutter, 13.2 psi, Luer Posterior PVC Tubing Set, Sterile, Single Use

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.