Alcon Valved Entry System Recalled for Potential Leakage
Alcon Research, Ltd. is recalling 83,448 units of 23G and 25G Valved Entry Systems because they may leak beyond design specifications.
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 medical device with a functional defect (leakage) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 83,448 units of the Alcon 23G and 25G Valved Entry System. This medical device provides access into the posterior segment of the eye for surgical instruments during Pars-Plana-Vitrectomy (PPV) surgeries. The recall covers specific lot numbers distributed in the United States and numerous international locations.
The recall was initiated because the product has the potential to leak beyond its design specification. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and consumers should stop using the affected units and contact Alcon Research, Ltd. for further instructions or a replacement.
The recalled product
- Product
- Alcon 23G and 25G Valved Entry System provides 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
- 83,448
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 (20)
- Lot Numbers: 15011624X
- 15013312X
- 15013313X
- 15014272X
- 15014273X
- 15015769X
- 15016782X
- 15016783X
- 15016784X
- 15018549X
- 15018550X
- 15018554X
- 15018602X
- 15018603X
- 15018606X
- 15018888X
- 15018890X
- 15020828X
- 15020830X
- 15021333X
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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