Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit
Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where a mechanical failure (detachment) could occur during surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Alcon Research, LTD. is conducting a voluntary medical device correction for specific 23G ophthalmic products. The affected items include the 23G non-valved trocar cannula and infusion cannula, which are sold together in various procedure packs and kits, such as the Accurus 23G TotalPLUS Pak and Constellation 23G Combined Packs.
The recall is due to a loose fit between the 23G non-valved trocar cannula and the infusion cannula. This issue could potentially cause the two components to detach from each other during ophthalmic surgery. The products are used to provide internal access to the ocular cavity and to maintain intraocular pressure during posterior segment surgeries.
The affected products were distributed worldwide, including in the United States and several international markets. A total of 93,319 units were distributed, with 30,413 units distributed domestically and 62,906 units distributed internationally. Healthcare providers and facilities should stop using these specific lots and follow the recall recommendation provided by Alcon.
The recalled product
- 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)…
- Manufacturer
- Alcon Research, LTD.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828
- 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814
- 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816
- 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058
- 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077
Distribution
Distributed nationwide across the United States.
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