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.
FDA Recall Z-1947-2014 · Posted 2014-06-30
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Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeLRO
Date Initiated2014-05-16
Date Terminated2014-12-09
Product Quantity684 total (525 units in US)
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
Firm Action
Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email [email protected].
Customers with questions were instructed to call 1-800-862-5266.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including North Carolina and Maine
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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