Diamatrix
Diamatrix · Model IT-.3-45 · UDI-DI 00813059015181
HMX
Prescription
10
510(k) clearances
810
Adverse events
28
Recalls
237
Facilities
Description
Irrigating/Aspirating 45° tip only, 16 Gauge Outer Sleeve, 21 Gauge Closed Inner Cannula tip with .3mm Aspirating Port, 19mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 37mm total length, Titanium with Stainless
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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Get your free API keyRead the docsData 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.