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 anterior chamber space and replace fluids that are lost during surgery.
Reported: July 9, 2014 Initiated: May 16, 2014 #Z-1947-2014
Product Description
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 anterior chamber space and replace fluids that are lost during surgery.
Reason for Recall
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 684 total (525 units in US)
- Distribution
- Nationwide Distribution including North Carolina and Maine
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
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 anterior chamber space and replace fluids that are lost during surgery.. Recalled by Alcon Research, Ltd.. Units affected: 684 total (525 units in US).
Why was this product recalled? ▼
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1947-2014.
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