Alcon Custom Pak
FDA Recall Z-0053-2018 · Posted 2017-08-25
Recalling FirmAlcon Research, LTD.
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-08-08
Date Terminated2019-08-05
Product Quantity33 units
Reason for Recall
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
Firm Action
The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon.
Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
Root Cause
Nonconforming Material/Component
Distribution Pattern
States in the US - WI, NY, MO
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.