This voluntary medical device correction is related to Alcon products… — Class II medical device recall Z-2470-2012
Terminated recall by Alcon Research, LTD., reported 2012-10-03, distributed nationwide. This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and i
| Recall number | Z-2470-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Houston, TX, United States |
| Recall initiated | 2012-05-29 |
| Classified | 2012-09-27 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, GB, GR, KW, SA, SG |
| Reason classes | device malfunction |
| Model numbers | 8065750842 |
Product
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
Reason for recall
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 between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2470-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.