Alcon Recalls 23G and 25G Valved Trocar Cannula Custom Paks
Alcon Research, Ltd. is recalling 30,701 units of 23G and 25G valved trocar cannula Custom Paks because the products have the potential to leak beyond their design specification.
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 is classified as FDA Class II, and the hazard involves a potential leak in a device used for eye surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Alcon Research, Ltd. is recalling 30,701 units of Custom Paks containing 23G and 25G valved trocar cannula. These medical devices are used to provide access into the posterior segment of the eye for surgical instruments during Pars-Plana-Vitrectomy (PPV) surgeries.
The recall was initiated because the products have the potential to leak beyond their design specification. The affected units were distributed in the United States and numerous international locations, including Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, Mexico, and the United Kingdom.
Healthcare providers and facilities should identify and stop using the affected lot numbers listed in the recall notice. Consumers are advised to contact their healthcare provider or the manufacturer for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
- Manufacturer
- Alcon Research, Ltd.
- Hazard
- Affected units
- 30,701
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Alcon Research, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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