Alcon Anterior Chamber Cannula Recall Due to Incorrect Component
Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.
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 involves a medical device used during surgery where the wrong component (a sharp needle instead of a cannula) could pose a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Alcon Research, Ltd. is recalling specific Alcon CUSTOM-PAKs that are supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) but actually contain a 27G Sharp Tip Needle. The affected products are identified by Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04, and include specific lot numbers listed in the recall documentation.
These products are typically inserted through an incision during cataract surgery to deliver balanced salt solution to help maintain anterior chamber space and replace fluids lost during the procedure. The recall involves 684 total units, with 525 units distributed in the United States. The distribution was nationwide, including North Carolina and Maine.
Healthcare providers and facilities should stop using the affected products and contact Alcon Research, Ltd. for further instructions on the recall process.
The recalled product
- Product
- Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help a
- 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 (9)
- Alcon Assembly Numbers 9795-37
- 11233-14
- and 13334-04 bearing Lot numbers 1584114H
- 1577346H
- 1595079H
- 1589608H
- 1585992H
- 1580988H
- and 1580492H.
Distribution
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