Recall Z-1947-2014— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2014-05-16, terminated 2014-12-09. It names one FDA 510(k) clearance: K880961. 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 anterior chamber space and replace fluids that are lost during surgery.. Reason: 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.
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-16
- Terminated
- 2014-12-09
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.