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Millennium

Avalign Technologies, Inc. · Model 92-4968 · UDI-DI 00190776384982

HMX Prescription

510(k) clearances

813

Adverse events

Recalls

235

Facilities

Description

Dankner Panariello 12 O'clock Cortex Cannula 23ga, gently curved shaft with 0.4mm aspirating port, 21mm OL

Recalls

Date	Firm	Reason
2025-09-06	Iantrek Inc.	Potential for compromised integrity of the sterile packaging.
2024-02-02	Beaver Visitec International, Inc.	Pack and pouch label is missing the manufacturing and expiration date.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-04-21	Anodyne Surgical	The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
2021-02-25	Dutch Ophthalmic USA, Inc.	Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281
2019-12-17	Vitreq Bv	Microscopic tears of the sterile pouch may compromise sterility
2019-12-17	Vitreq Bv	Microscopic tears of the sterile pouch may compromise sterility
2019-12-17	Vitreq Bv	Microscopic tears of the sterile pouch may compromise sterility
2019-12-17	Vitreq Bv	Microscopic tears of the sterile pouch may compromise sterility
2019-12-17	Vitreq Bv	Microscopic tears of the sterile pouch may compromise sterility

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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.