Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage
Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.
What this means for you
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 medical device used in eye surgery that may leak beyond design specifications, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks. These medical devices are used to provide access into the posterior segment of the eye for surgical instruments during 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
The recall was initiated because the products have the potential to leak beyond their design specifications. The affected units were distributed in the United States and numerous international locations, including Argentina, Australia, Canada, China, Germany, Japan, and the United Kingdom.
Consumers and healthcare providers should stop using the affected products and contact Alcon Research, Ltd. for further instructions. The recall covers specific lot numbers listed in the official FDA documentation.
The recalled product
- Product
- 23G and 25G Constellation Totalplus Paks 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.
- Affected units
- 225,000
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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