Alcon Custom Pak Recalled for Potential Glove Splits and Holes
Alcon Research, Ltd. is recalling Alcon Custom Paks because the Devon Light Glove component may have splits or holes, which could lead to surgical site infections.
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 involves a risk of surgical site infection, which is a significant health hazard, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Alcon Research, Ltd. is recalling Alcon Custom Paks, which are assemblages of single-use medical devices and accessories designed for specific ophthalmic surgical procedures. The recall is limited to Paks that contain the Devon Light Glove.
The supplier of the Devon Light Glove initiated the recall due to the potential for splits and holes on the glove. If a user is unaware that the Light Glove is torn or split, surgical site infections are possible.
The affected units were distributed worldwide, including the United States, Australia, and Canada. A total of 219,680 units are involved in this recall. Users should check their inventory for the specific lot codes listed in the official recall notice and stop using any affected Paks.
The recalled product
- Product
- The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
- Manufacturer
- Alcon Research, Ltd.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 219,680
Distribution
Distributed nationwide across the United States.
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