Diamatrix
Diamatrix · Model H410-L-T · UDI-DI 00813059016775
HNQ
Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
188
Facilities
Description
Nagahara Diamatrix Phaco Chopper, Intended to be used in the left hand, Flat interior cutting edge, Angled 10mm from bend to tip, Round knurled Handle, 114mm total length, Titanium
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2022-03-16 | Carl Zeiss Meditec AG | High friction of the slider can cause the device to stick, or not move as intended. |
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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.