Home › D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. › Disposable One Step Cannula System (25 gauge/0.5 mm)
Disposable One Step Cannula System (25 gauge/0.5 mm)
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Model 1272.ED205 · UDI-DI 08717872017372
NGY
Prescription
1
510(k) clearances
346
Adverse events
11
Recalls
61
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Alcon Research LLC | Due to incomplete seals in the pouch which provide the sterile barrier. |
| 2023-02-20 | Mani, Inc. - Kiyohara Facility | A packaging defect may compromise the sterile barrier. |
| 2020-10-27 | Mani, Inc. - Kiyohara Facility | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| 2020-10-27 | Mani, Inc. - Kiyohara Facility | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2012-05-29 | Alcon Research, LTD. | This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit b |
| 2009-04-29 | Alcon Laboratories, Inc | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
| 2009-04-29 | Alcon Laboratories, Inc | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
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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.
